Quality Assurance and Validation

Quality Assurance (QA) Management Procedures In this episode you will find Standard Operating Procedures for establishing quality assurance practices, such as preparation, maintenance, definition, classification and change Control of Quality and Master file documentation necessary for your products; recording and reporting procedure for deviations management; quality concern investigation Process; customer complaint handling procedure; quality audit procedures; vendor assessment, evaluation and certification procedure; rework procedures for the defective manufactured products; procedures on training for your staffs and many other procedures according to your need. All procedures have reference of prepared Forms and Templates for effective record keeping and reporting purposes. Forms are attached at the end of each procedure. Templates are listed separately. SOP list Writing Standard Operating Procedure This SOP describes standard SOP format that you can create and use immediately for your quality procedures. This SOP has instructions on how to write a formal Operating Procedures for your systems which your people can follow everyday. GMP Documents In this SOP you will find all type of quality and Technical/Master file documents to build up a good quality management system for your manufacturing sites, definition of documents, their classification, approval requirements and retention requirements. This procedure has schematic diagrams for your understanding of how different types of documents are prepared and stored in a typical documentation database. Quality Documentation Change Control This SOP describes how to generate new quality documents or change control of existing documents, review of quality documents, satellite file management, role of document author, approver, document control officer and satellite file administrator. In this SOP you will also find numbering systems of different quality documents like audit files, SOPs, forms, manuals, training files, QA agreements, project files etc and their effective archiving system. Documentation Rule This SOP describes the principles to be followed in GMP documents, entry of data and information, signature requirements and correction technique of incorrectly entered data or information. Document Control In this SOP you will find mainly the role of document control officer during the initiation, creation, circulation and approval of new quality related documents. It also describes

the procedure of modification and review of existing document using a documentation database. Management of existing and superseded documents is also a part of this procedure. You will see all the forms referred during the instruction are attached at the end of the procedure. Master GMP Documents This SOP particularly focused on the management of master file documents like specifications, control methods, raw materials, finished goods and packaging specification and test reports, formulation, stability files etc required to generate during the product registration in the market. This SOP gives instruction on their creation, change control, numbering system, approval requirements and maintenance in a simple master file database. You will see all the forms referred during the instruction are attached at the end of the procedure. Deviation Reporting It is a regulatory requirement to capture all sorts of deviations evolves in your systems in order to maintain the continuous improvement of your processes and systems. This SOP describes how to categorize the deviations between production, audit, quality improvements, technical deviations, customer complaints and environmental, health and safety deviations. It describes the management responsibilities of initiating deviation, capture data, analysis, investigation, determination of assignable causes, generation of management report and initiatives to be taken on corrective and preventative actions. Product Shelf Life This simple SOP describes the meaning of shelf life and provides direction on how to interpret shelf lives and storage conditions for your raw materials from the Certificate of Analysis, determining expiry date for your finished products by use of raw material date of manufacturing and their shelf lives. Vendor Management This SOP describes the procedure to be followed during the vendor assessment and vendor evaluation for purchasing of raw materials, critical and non critical packaging components, laboratory supplies, engineering supplies and imported finished goods from the vendor. These instructions are essential for approving prospective vendor. Vendor Certification This procedure aims to describe the process by which a vendor may be certified to supply materials or services. This procedure applies to vendors that supply a material or service to be used at any stage of manufacture by operations. Here you will get the roles of each department in the process to certify an approved vendor. Product Complaint This procedure covers the receipt, logging, evaluation, investigation and reporting system of all complaints received from customers for the marketed products. This SOP contains step by step instruction to be followed in the customer complaint management

like numbering of complaint, registration, evaluation of complaints, determination of assignable cause for the complaint deviation, implementation of corrective and preventative actions, trending of complaints and handling of counterfeit products. Product Review This procedure provides a guideline to annual product review which is required to be performed for each product produced for the commercial market to evaluate data, trends and to identify any preventative or corrective action that would lead to product quality improvements and report them to management. Rework This SOP contains the step by step instruction to be followed when the rework of an inprocess or completed finished good is required. This SOP covers the reworks of inprocess manufactured goods where new batch number is introduced for the reworked part and rework of manufactured finished good keeping the same batch number. This sop also describes how to create rework protocols for each individual case. Product Identification and Traceability The purpose of this SOP is to define the method used for the identification of all contributing materials that could affect product quality and to ensure their full traceability. Here you will find instruction on all the records and documents used for the identification and traceability of incoming raw materials and out going finished goods. GMP Audits This SOP describes the process of planning, performing, reporting and follow-up of different audits for your systems like Internal Quality audit, Vendor audit, Environmental Health and Safety (EHS) audit, EHS workplace inspection, Housekeeping audit. This SOP also describes the process to be followed by manufacturing personnel during an audit from a Regulatory authority. Batch Documentation This SOP describes the identification of all documentation relevant to a production process in the form of “Batch Documentation Checklists” and to ensure their collection by completion of the checklists by Authorized Persons. This procedure is based on an example of tablet packaging process described in the „Manufacturing‟ category. Batch Document Evaluation for Release This procedure describes the process of collection, evaluation and record of batch related document generated during the production of a batch before an authorized person can release the batch for sale. This procedure is based on an example of tablet packaging process described in the „Manufacturing‟ category. GMP Training This SOP describes how to design and deliver GMP related trainings for your manufacturing staffs, training assessment design, recording of assessment and preparation of training reports.

GMP Training Materials This simple SOP contains instructions on how to write training materials, identification of training requirements, available resources, preparation of training aid checklists for your manufacturing staffs. House Keeping Audit This SOP describes the requirements, checklists and reporting procedure on housekeeping audits. Individual checklist forms are attached at end of the procedure for different areas like process, laboratory, engineering stores, warehouses. This procedure also describes the handling of non-compliance found during the housekeeping audits. Contract Work The procedure describes the management and control of contract work provided by the contractors for packaging and finished products for your company as well as control of contract works done by your company on behalf of others. Raw Material and Packaging Components Sourcing The purpose of this SOP is to describe the process for approval of an external vendor/manufacturer supplying products to your company. It covers raw materials (including bulk products for subsidiaries and contract manufacturers), critical packaging components in contact with product and imported finished goods. The SOP also references affiliated documentation detailing the scope of active materials used and the approved manufacturers of these materials. Quality Investigation Process This procedure contains instruction to be followed when conducting Investigations and to raise and assess Deviation Report when an Investigation or Incident Investigation occurs. This procedure is to be used in conjunction with Deviation management, which covers the approval and follow-up activities associated with a Deviation Report. Here you will find collection of information for an incident or a deviation, steps to be followed for a cross functional investigation, reporting and implementing of the outcomes of investigation. Change Management System This procedure provides a standardised procedure and framework for initiating, authorising, planning and implementing any change to a GMP system. Product Change Management requires that all planned permanent changes that have the potential to impact on regulatory filings or the quality of an active pharmaceutical ingredient or drug product must be evaluated, reviewed and approved. It also requires that the site procedure must include provision for effectively tracking all quality and regulatory changes and provide a mechanism for review and approval by the Site Quality Team for all changes Cross functional investigation

This procedure describes the guidelines for initiating, communicating, conducting and documenting Cross-Functional Investigations (CFI) related to process, system, product, material, facility and laboratory deviations. A Cross–Functional Investigation is an extended investigation conducted in order to identify a Root Cause.

Quality Control Laboratory Procedures In this episode you will find practical procedures on Retest Dating of Raw Materials; Calibration Policies for Laboratory Instruments; Archiving Laboratory Documentation; Management of Reference Substances; GLP requirements of Laboratory Workbook; Creation of Certificate of Analysis; Managing Analytical Reagents; Laboratory Waste Management; Managing of Retention Samples in Laboratory; Laboratory Supplier Approval; Laboratory Results-Out Of Specification Investigation; Raw MaterialsLaboratory Testing and Documentation; Finished Goods-Laboratory Testing and Documentation; Preparation and Maintenance of Stability Protocols (pharmaceuticals); Stability and Trial Testing Procedure (pharmaceuticals). SOP lists Retest Dating The purpose of this procedure is to describe how to run the expired stock report; to describe how to define the requirements for the retesting and assignment of storage periods for active ingredients, excipients and raw materials; to instruct retesting procedure and to determine the status of a finished goods batch with a shorter shelf life. Calibration of Laboratory Instruments This SOP describes the calibration policies of laboratory instruments/ equipments. It describes labeling and security requirements of laboratory instruments/ equipments. This SOP also describes the investigational steps to be required in the case of failed calibration. Archiving of Laboratory Documentation This procedure describes retention and disposal procedures of laboratory documentation, general laboratory documentation system that includes handling of rejected raw material and finished product reports, finished goods certificate of analysis, finished goods register, raw material certificate of analysis, raw material register, trend cards, procedure for long term document retention. Reference Substances This SOP describes the ordering, referencing, storing, coding, use and general register maintenance of primary and impurity reference substances, primary reagent reference solutions, secondary raw material reference substance, assay testing procedure of secondary raw material reference substance, use of secondary raw material reference substance in the laboratory routine analysis, determination of expiry date and re-test date of reference substances. Laboratory Workbook This SOP describes types of laboratory workbooks, general and GMP requirements of using workbooks, analytical data entry in the workbook, formatting of laboratory workbooks for routine testing, experiments and trials, workbook retention policy, instruction on data entry for incomplete experiments and additional data.

Certificate of Analysis The purpose of this procedure is to define the content and format of a Certificate of Analysis (C/A) and Certificate of Manufacture (C/C) and to provide guidance for issuing a Certificate of Analysis or Certificate of Manufacture and to locate the appropriate data required for this task. Analytical Reagents This procedure identifies the need for all analytical reagents and solutions prepared from the reagents, to have an assigned expiry date and storage conditions recorded on the label. Here you will find the procedure for purchase and management of analytical reagents and laboratory prepared reagents. Laboraotry Waste Management This simple procedure describes how to dispose off laboratory generated wastes of toxic, explosive, flammable, corrosive, oxidizing and biologically damaging natures. Laboratory Retention Samples The purpose of this SOP is to describe the finished good and raw material sample retention procedures, products manufactured and/or received onsite and/or chemically tested by the Laboratory. Laboratory Supplier Approval In this simple SOP you will find the procedures for approving laboratory suppliers and criteria for the purchase of equipment, instrumentation, consumables, durables and glassware for the laboratory. Laboratory Results Out Of Specification Investigation This procedure describes the actions to be taken by an analyst in the event the result of a test does not conform to raw material/components or finished products specifications for physical and chemical tests. An out of specification (OOS) result does not necessarily mean the batch under investigation fails and shall be rejected. The OOS results shall be investigated and the findings of the investigation, including re-test results shall be interpreted to evaluate the batch and reach a decision regarding release or rejection. Laboratory Testing for Raw Materials This SOP describes the procedure for sampling, location, pre-testing, testing and documentation of all raw materials and components subject to test, out of specification results, microbiological tests and release procedure for passed raw materials and components. Laboratory Testing For Finished Products This SOP describes the procedure for sampling, location, pre-testing, testing and documentation of all finished products subject to test, reagents and standards to be

used for analysis, management of out of specification results, microbiological tests and release procedure for passed finished goods. Stability Protocols This procedure describes the preparation and management of Stability Protocols for marketed products. This procedure is applicable to all protocols for stability studies on commercial products. The responsibility of the commercial Site Stability Manager for creating and maintaining protocols that are required for studies that came as a result of validation or process deviation. Trial Testing To describe the steps necessary to ensure the effective control of stability and trial testing programs of new and existing products. This procedure is focused on setting up of stability programs, testing, reporting, general sampling procedure for stability programs, data generation and analysis, annual maintenance of stability, new product stability procedure, procedure for in-house trials, reporting and interpretation of trials and conclusion of the trail program. Preparation of Disinfactant Solution in the Lab This procedure describes the preparation and use of disinfectant solutions (70% IPA) in the Sterile Area and also outlines the procedure for Integrity testing of the 70% IPA Filter. Laboratory Analytical Determinations The purpose of this document is to describe the operational procedures to be followed when carrying out analytical analyses in the Quality Control Laboratory at a GMP site. This SOP outlines the system suitability (SST) and acceptance criteria for analysis by HPLC and UV-VIS Spectrophotometer; e.g. Composite Assay (Assay), Degradation Products / Related Substances / Impurities (Degradation), Content Uniformity (CU), and Dissolution tests for all Raw Materials, In-process, Finished Products and Stability Samples in the QC Laboratory. This SOP also covers the number of standard and samples to be weighed for HPLC and UV-VIS Spectrophotometers analyses. HPLC Reproducibility, Column Performance and Testing Guidelines The purpose of this document is to describe the Reproducibility checks of the High Performance Liquid Chromatograph, Column Performance and guidelines for assay testing on the HPLC. HPLC Method Development & Validation Procedure The validation of an analytical method is the process by which it is established that the performance characteristics of the method, such as Precision, Accuracy, Specificity, Linearity, Limit of Detection (LOD), Limit of Quantitation (LOQ) and Robustness meet the requirements for the intended applications. This SOP refers specifically to HPLC. However, the same principles may be applied to validations of other types of analytical procedures. Well-characterised reference materials with documented purity should be used to perform the validation.

The optimum wavelength for a method can be found by acquiring the chromatographic data on a PDA detector over a large wavelength range, (e.g. 200-400nm). The optimum wavelength is the wavelength, which maximises the response for all the components of interest, but is outside the absorbance for the mobile phase. Before validating an HPLC method, its Specificity must be determined. If the method does not comply with the Specificity requirements, the method must be modified until the acceptance criteria are met. Hence it is essential that the Specificity be adequate, before Precision, Linearity and Accuracy, etc. are performed. Laboratory In Process and Finished Product Quality Control This purpose of this document is to outline the procedure to be followed for the receiving, scheduling, testing, reporting, reviewing, approval and release of In-process and Finished Products in the QC Laboratory at a GMP site.

Microbiology (Sterility) Laboratory Procedures In this area you will find Standard Operating Procedures on Entry Procedure to Sterile Filling Areas, Validation of Aseptic Gowning Procedures, Microbiological Data Recording Procedure, Destruction of Biological Waste in the Microbiology Laboratory, Depyrogenation of Glassware In Micro. Lab. Oven, Media Preparation in Microbiology Laboratory, Aseptic Media Filling and Micro. Integrity Leak (Soup) Testing Procedure, Aseptic Media Filling and Soup Test Guideline, Environmental and Plant Hygene Monitoring Procedure, Microbial Limit Testing Procedure by Using Laminar Flow Cabinets etc and many other procedures according to your need. All procedures have reference of prepared Forms and Templates for effective record keeping and reporting purposes. Forms are attached at the end of each procedure. Templates are listed separately. SOP List Sterile Entry This SOP outlines the gowning procedure that must be followed by each and every person who enters a Sterile Area. The procedure is designed to reduce the risk of contaminating product with bacteria and/or particles Aseptic Gowning Validation Aseptic gowning is the ability to complete the gowning procedure without compromising the sterility of the garment. This SOP outlines the sterile gowning validation procedure as required for the final sign off for the initial sterile training and the revalidation of currently trained Operators, Fitters, Electricians and Cleaners and all organization staff who are authorized to enter Sterile areas. Microbiological Data Recording To describe procedures for the recording of Microbiological data using the in-house hard copy and computerized recording system. All documents containing test results are legal documents and therefore it is imperative that all the information required is recorded accurately. Any changes/corrections to be made must be signed with that person‟s initials and dated. Biological Waste Destruction To describe procedures for destroying all Laboratory Biological Waste to comply with Quarantine Regulations Depyrogenation of Glassware To outline the procedure for the depyrogenation of glassware using the Microbiology Laboratory Qualtex Oven. Media Preparation

To describe the procedures for the preparation of microbiological media for use in the Microbiology Laboratory. Micro. Integrity Leak (Soup) Testing One of the requirements of cGMP is a periodic evaluation of all aseptic processes by filling media into the appropriate containers under normal production conditions. The media fill should reflect the sterility of the entire process from the Sterilizing filter to the filled primary container and should include all subsequent manufacturing steps. This SOP outlines the procedures for both Media Fills and Microbiological Leak Tests. For Validation purposes, a Microbiological Leak Test (Soup test) or a separate Protocol to verify the entire process from the „Bioburden Reduction Filter‟ to the primary container may be required. Aseptic Media Filling and Soup Test Media Fills are designed to verify the entire process, equipment and staff. This process simulation should be performed as initial validation with three (3) consecutive satisfactory simulation tests per shift and repeated at defined 6 monthly intervals (twice per year per process per shift) and after any significant modification to the HVACsystem, equipment, process and number of shifts” for aseptically filled process. Soup test has to be conducted at least once per year per shift for terminally sterilised lines and non-sterile process. Validation and re-validation media fills are to assure the sterility of the entire process. This process simulation test should imitate as closely as possible the routine aseptic manufacturing process and include all the critical subsequent manufacturing steps. The Media Fill should challenge the “worst case” situation and should include all the possible interventions of a normal production run. The duration of the media run should be at least 4 hours or half a production shift to allow for all routine interventions. Environmental and Plant Hygiene Monitoring Description for Microbiological testing of areas of the environment which may influence or affect product performance and/or quality-including, air, surfaces, personnel, clothing and disinfectants. Daily monitoring of sterile grade areas during production is to be conducted by trained production staff. The Microlab is to ensure that the necessary plates are delivered on a daily basis so monitoring can take place. Once a test has been completed, the responsible operator is to initial the plate and make sure that the batch number of the batch running at the time of the test is written on the plate. Plates will be labeled with prompts to ensure this isn‟t forgotten. If no batch is running at the time of the test N/A should be put on the plate instead of a batch number. If an area of concern is noted during routine daily testing, inform Micro immediately so that further steps can be taken. Microbial Limit Testing Using Laminar Flow Cabinets. To describe the procedures to be followed in conducting Microbial Limit Tests in the Laminar flow Cabinets in the Microbiology Lab. Microbiological Monitoring of Plant Water Systems

In this SOP you will find Sampling Procedure for Bioburden and Endotoxin Samples, Bioburden Test Method and Results, Endotoxin Testing of WFI (Distilled Water), Bioburden and Bacterial Endotoxin Alert and Action Levels, Diagrammatic Representations of a typical purified Water Systems, Bioburden Waste Tank Water Sampling, Clean Steam Sampling & Testing, OOL/OOS Result Actions etc Sterility Testing Procedure This sop is to describe the procedure for sterility testing of aqueous, injectable and terminally sterilized non injectable products. To explain the correct interpretation of sterility results and to outline Stasis requirements for used sterility canisters. Determination of Heat Resistance of Spore Forming Organisms This SOP describes the method for calculating the Heat Resistance Factor, (D-value),of spore-forming organisms. D-Value is defined as the time required for a population of a pure culture of microorganisms to be decreased by 90% when exposed to a fixed temperature, e.g. 121°C (+1°C). Identification of Microorganisms to Genus and Species Level To describe the procedures for the preliminary identification of bacteria isolated from Plant Water, Environmental, Personnel, Product and Raw Material sources. Bacteria that will require identification (ID) to at least genus level include organisms isolated from the manufacturing environment, personnel, in-process and finished products, plant water and other miscellaneous sources. SOP‟s detailing the microbiological testing procedures for each of these samples will indicate the required level of ID of recovered organisms. The following sections detail the procedures for the preliminary ID of microorganisms. Further ID to species level is to be conducted for conformation. Micro Evaluation on Bioburden, Non sterile and Raw Materials This SOP describes the procedures for Microbiological Evaluation of Bioburdens, nonsterile Products & raw materials. Bioburdens includes: Batches prior to membrane filtration, i.e. solutions; Batches prior to sterilization i.e. filled containers; Face masks; IPA. This procedure includes Equipment preperation for Non-sterile testing, Bulk Solution Bioburden (BSB) Sampling; Filled Container Bioburdens (FCB); Raw Material Bioburdens (RMB); Surgical Face Masks; Isopropyl Alcohol (70% IPA); Speciation Procedures for Organisms found in Non Sterile Products and Raw Materials; Out-ofSpecification Procedures for Non Sterile Products and Raw Materials; Retest and Repeat Procedures for Non-Sterile Products and Raw Materials. Bacterial Endo Toxin Testing (LAL) - Gel Clot Method To describe the procedure for conducting a Bacterial Endotoxin Test by the LAL GelClot method. The gel-clot method for bacterial endotoxin testing described in this SOP is based on the fact that Limulus Amoebocyte Lysate (LAL) will form a firm gel in the presence of bacterial endotoxin. Bacterial Endo Toxin Testing kCA Method

The purpose of this SOP is to outline the theory of Bacterial Endotoxin testing using Kinetic Chromogenic Analysis (KCA). And to outline the procedure for routine product testing, operator / reagent verification and product validation by KCA using the BioWhittaker KQCL (brand) reader. This Procedure also describes the routine maintenance procedures for the BioWhittaker KQCL (brand) reader. Stock Suspension of Micro Organism The objective of this SOP is: To describe the method for preparing and maintaining stock suspensions of vegetative microorganisms and spores used within the Microbiology Laborator;. To explain the procedure for growth promotion and media verification requirements for all media used within the Laboratory; To outline requirements for Stasis testing on sterility canisters after sterility testing has been completed. Sterile Sampling Procedure for Microbiology Laboratory To detail the procedure for taking Microbiological samples for Sterility testing, Bacterial Endotoxin testing, Bioassay testing, Microbial Limit test and Micro status testing throughout Production. This procedure includes sterilization charts, Settle plates (Fallout plates) and Personnel monitoring. Gel Clot Validation Method The gel clot validation method for Bacterial Endotoxin testing described in this SOP, is to determine the level of Inhibition/Enhancement of products on the LAL test for endotoxins within the allowable Maximum Valid Dilution (MVD) for each type of product. The Gel-Clot techniques detect or quantify endotoxins based on clotting of the LAL reagent in the presence of endotoxin. To be determined for each type of product, using the highest and lowest concentration of active. If either concentration shows inhibition or enhancement, then each remaining concentration must be tested. At least three (3) Production batches of each finished product should be tested for inhibition and enhancement. Laboratory Investigation for Atypical and OOS Results The purpose of this procedure is to provide guidance when investigating microbiology laboratory out of specification (OOS) results associated with raw material samples, inprocess samples and finished product samples. This procedure describes the actions taken by Microbiology Laboratory staff in the event the result of a test does not conform to company specifications for microbiological release. This procedure will also provide guidance for re-testing raw material samples, in-process samples and finished product samples when it has been decided through a laboratory investigation that retesting is justified. Retesting should be viewed as an investigational tool to aid in determination of the root cause of the discrepant laboratory result. IPA Contamination Testing Procedure To describe the test sometimes used to check the purity of the IPA used in the factory as a disinfectant.

Control of Microbiology Test Methods This document details the writing, control, and distribution of Microbiological Test Methods (MTM) for use in the GMP Microbiology Lab. This procedure applies to Microbiological Test Methods that are controlled from beginning to end by the Microbiology Lab Manager. Handling of Test Sample in Microbiology Laboratory This document details the handling of test samples (raw materials, bulk product and stability samples) processed for Microbial Limits Testing (MLT) in the Microbiology Laboratory. This procedure applies to samples tested for Microbial Limits within the Quality Control Microbiology Laboratory. Documentation Requirement For Micro Test Method Validation The procedure describes the process for accessing and using protocol templates for documentation of test method validation activities in the Microbiology laboratories. This procedure applies to Microbiology personnel responsible for the validation or verification of microbiological test methods. The procedure outlines the requirements for approval of method development protocols, validation/verification protocols and final validation summary reports

Process, Cleaning and Methodology Validation Procedures In this area you will find procedures on validation-concept and procedure, revalidation procedure, method validation procedure, procedure for cleaning validation, validation of laboratory instruments, equipment specification and qualification and in-house trial procedure. All procedures have reference of prepared Forms and Templates for effective record keeping and reporting purposes. Forms are attached at the end of each procedure. Templates are listed separately. SOP list Concept and Procedure of Validation This procedure describes general validation concepts and practices, the way processes and systems must be qualified/validated and the confirmatory documentation required. Here you will find the philosophy of validation, responsibilities, validation approaches of design qualification, installation qualification, operational qualification, performance qualification, cleaning validation, method validation, computer validation, general and specific criteria of validation, validation documentation and change control, validation reporting, guidelines of validation acceptance criteria. Revalidation This procedure contains step by step instruction on initiation of revalidation categories, changes that warrant revalidation programs, basic steps of revalidation procedure, revalidation activities and specific responsibilities, revalidation protocols, revalidation timing, equipment checklist, revalidation discrepancy procedure, release of revalidated equipment, preparation of the revalidation reporting file. Method Validation This procedure provides a guideline for a validation Technician on the characteristics that must be considered during the validation of an analytical testing procedure. The procedures set out in this SOP apply to qualitative and quantitative analytical methods which are used to test finished goods, in-process material, excipients and raw materials in support of registration documentation and cleaning validations and management responsibilities towards completing those method validation tasks. Cleaning Validation This SOP describes the types of cleaning process and cleaning agents of process equipments and their validation, complete instruction on cleaning validation procedure, calculation of acceptance limits for rinse and swab samples, calculation of acceptance limits for swabs, analytical method validation for cleaning, cleaning validation test protocols and change control for revalidation. Validation of Laboratory Instruments

This procedure describes the validation practices for laboratory instrument/equipment to be validated or calibrated and the confirmatory documentation required showing that the instrument/equipment is capable and operating effectively for its intended purpose. This procedure has practical instruction on Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) to be performed by the qualified equipment service technician in the presence of the laboratory staff with reference to the instrument/equipment manual. Equipment Specification and Qualification This procedure describes in detail the procedures for the procurement of equipment, incorporating standardized demand specifications and Installation Qualification documentation, to ensure that equipment procured complies with in-house requirements and standards and conform to Good Engineering Practice, to detail the general procedure to be followed regarding the reporting of Factory and Site Acceptance Tests, to detail the manner by which the equipment Installation Qualification is documented. In-House Trial The purpose of this SOP is to define common procedures to follow when organizing Trials/Evaluation Studies for the purpose of process improvement, equipment capability and validation studies. It defines the responsibilities within the trial process and documents that need to be considered when preparing the Trial documentation to ensure that the trial meets GMP and where applicable validation requirements. This SOP defines the procedures for conducting in house stand-alone trials on systems, processes and equipment. There can be an overlap between a trial and validation in that Trial documentation may form part of a latter process validation, (i.e. concurrent and prospective validation) and qualifications (OQ, PQ). Computerized Systems Validation To overview the procedure to be followed for the Qualification/Validation of computerized systems. This procedure applies to all computer systems (including embedded systems) directly associated with, or supporting, regulatory compliance requirements for the development, testing, manufacture and distribution of medicinal products. Impact Assessment for Computerized Systems The purpose of this SOP is to provide a method of assessing and determining the validation requirements for computerized systems and controllers. The SOP identifies the typical qualification activities required for those systems having a Direct or Indirect impact on product/process quality and data integrity, should the system fail or malfunction. These activities are in addition to Good Engineering Practice (GEP), which is appropriate for all systems, and is also outlined Functional Testing Guide for Computerized System This SOP provides guidance on functional testing during the development or change of computerized systems which have GxP impact at a GMP manufacturing site. What

constitutes a change to a computerized system is described in manufacturing change control procedure. Design Qualification Guidelines The purpose of this document is to provide guidelines on conducting Design Qualification (DQ) during the conceptual and detail design phase for the implementation of a GMP facility, process and equipment (including computerized systems) to ensure conformance to operational and regulatory expectations. The guideline will provide the basis for conducting and documenting Design Qualification to all projects involving the introduction of, or significant change to, any facility, system or equipment that potentially impacts on product quality and is suitable for its intended purpose. Protecting the Reliability of Electronic GMP Records This SOP applies to records created, processed, used or stored by (or for) the GMP Manufacturing site, that are the output of a computerized system. It is of particular relevance to records that have a GMP role, i.e. supporting product quality, patient safety or regulatory compliance. The guideline may also be used for other computerized systems that are classified as business critical.

GMP | Manufacturing Procedures In this area you will find exciting procedures on Clothing Requirements Inside the Factory Area, Cleaning Responsibilities and Methods for Employees, Factory Cleaning Procedure, Manufacturing Pest Control, Tours of Factory, Requirements of Production Logbook, Packaging Configuration for Production Line, Checking of Components Prior to Use, Tag Out Procedure, Procedures for Line Clearance, Line Opening and Line Cleaning, Reconciliation of Component and Product, Operation of Barcode Reader as an example, Intermediate Bulk Container (IBC) Operation and Cleaning, Tablet Packing Machine and Cartoner-construction, operation and cleaning as an example, Manufacturing Instruction for Tablet Packing as an example, Mop Cleaning Procedure, Scheduling Production Lines, Vacuum Leak Testing Procedure, Weighing Equipment Checking and Calibration, Operation of Checkweigher as an example, Tablet PackingStart up and In-process Testing as an example, Packed Tablet Sampling by Production Personnel for Testing as an example All procedures have reference of prepared Forms and Visual Displays for effective record keeping and reporting purposes. Forms are attached at the end of each procedure. SOP list Clothing Requirements This SOP covers the clothing requirements needed in all Factory areas for your manufacturing site. The different levels of cleanliness must be maintained to minimize microbial and particle contamination. This procedure contains general rules and restriction to be followed by your manufacturing employees, defining different environmentally graded areas and entry requirements for those areas. Cleaning Responsibilities and Methods This SOP describes the cleaning procedures to be followed by all employees working in the manufacturing area in order to prevent contamination of product by foreign materials from another batch, or by dirty parts, which may contain bacteria. This SOP contains instruction on responsibility of cleaning, degree of cleaning to be done, popular cleaning aids and solutions permitted to use for cleaning, rubbish removal and outline of cleaning methods for different environmentally graded areas. Factory Cleaning This SOP defines the methods, frequency and the intensity of Factory Cleaning. The purpose of cleaning is to remove debris from within the plant in a sanitary and effective manner and to avoid contamination from dust or foreign materials. This procedure describes which popular cleaning aids and solutions are to be used to clean the floors, walls, sinks and windows in the Production areas, office areas, change rooms, workshops, laboratories, stores, canteens, plus the toilet facilities. This procedure also describes the scope and responsibility of contract cleaners.

Manufacturing Pest Control This SOP describes the responsibilities of all employees and pest control services, classification of pests, frequency of the pest control service and effective treatments against all types of pest. Production Logbook This procedure outlines the generation, maintenance and filing of Production logbooks. Production logbooks form part of the documentation system required by the Code of GMP to provide complete and up-to-date histories of all batches of product. The logbook provides a key link in the process of traceability. Packaging Configuration for Production Line This SOP provides an alphabetically indexed diagram of shipper packing and pallet packing configurations for any packaging process. This procedure contains schematic diagrams of different packaging configurations and calculations of total unit to be packed per container which can be useable into your packing lines. Checking of Components before Use This SOP sets out a procedure to ensure that only components of correct code and batch number are issued for a batch and only issued components will be used in a finished product batch. This SOP also describes the procedure to be followed during returning of components to warehouse from the production lines. Tag Out Procedure This SOP describes how to prevent the risk of personal injury or damage to equipment likely to be caused by operating or attempting to operate machinery or equipment diagnosed as being unsafe, in need of repair or maintenance or formally removed from service. The SOP covers all isolation, condemning, repair or maintenance work that necessitates a device or machine to be taken out of service. This SOP applies to any situation where energy (either supplied to equipment, or stored within it) needs to be isolated to ensure the safety of any person working on or near equipment, processes or services - for any reason whatsoever. Line Clearance, Line Opening and Line Cleaning This SOP describes the procedure and order to be followed when performing a Line clearance, Line opening and Line cleaning for a batch production. The procedure has been established to prevent mix-ups of products, containers, components, labels and mistakes in documentations. Mix-ups and mistakes can occur when correct procedure and GMP are not followed. Particular care should be taken when starting a new operation, at the change of shift and when additional components are needed. In this procedure you will find example of line clearance, opening and cleaning checklist based on an example of tablet packing line. Reconciliation of Component and Product

This simple SOP describes the concept of reconciliation, how to reconcile finished goods and determine the allowable discrepancies of components and products when reconciled. Construction, Operation and Cleaning of Tablet Packing Machine This procedure describes the machine construction and operation, machine start up and cleaning of a typical tablet Blistering machine and the Cartoner for tablet packing. You will be able to create a new procedure for your packing line based on the format of this SOP. Manufacturing Instruction for Packing This procedure describes how to create a complete manufacturing instruction for your process line to be followed by your manufacturing employees. To make the instruction more practical and easy to understand, a sample instruction is added in the form of a protocol for a typical tablet packing process. All the related blank forms are attached at the end of the procedure for a better understanding. Mop Cleaning This simple procedure outlines the operation of the factory laundry in a safe and hazardfree manner. This procedure can be used in any manufacturing site for the purpose of mop cleaning. Scheduling of Production Lines This procedure describes how to produce a monthly manufacturing schedule following an agreed 12 months plan, to provide a sequence of work that will enable the scheduling of support groups (i.e. Quality, Technical and Warehousing), incorporate any planned engineering down time (i.e. project work, calibration and preventative maintenance), create and release batches according to the agreed weekly schedule, provide key dates for product supply to support Customer Service. Vacuum Leak Testing Procedure This SOP describes the set up and operation of a standard vacuum Leak Tester for the very popular vacuum leak testing used in a typical packing line. Tablet Packing-Start up and In-process Testing This procedure contains instructions that enable the production operators working in a typical packing line to carry out Start-Up and In-Process Tests required in order to produce quality products and to ensure in-process controls. A typical tablet packing process is used here as an example. Finished Product Sampling for Testing This procedure describes the process of sampling manufactured finished good required to be taken by production personnel for the laboratory testing. A typical tablet packing process is used here as an example. Returning Components from Packaging Floor

This procedure describes the steps to be followed when there are packaging components to be returned to the warehouse after the packaging operation has been completed.

Warehouse Management Procedures In this area you will find procedures on Receipt of Incoming Goods, Raw Material and Components-Incoming-Handling by Sampler, procedure for Warehouse to Processing Issues, Returns and Rejects, Dispatch of Goods from Warehouse, Warehouse Inventory Management, Warehouse Locations and Storage Area, Finished Goods Transfer to Quarantine and Distribution Warehouse, Sampling of Raw Materials, Sampling of Components and Printed Materials, Work in Progress Area, Safety Procedure of Warehouse Racking, Forklift Operation in Warehouse, Tablet Dispensary Procedure as an example, Raw Material Tablet Sampling by Dispensary as an example, Material Purchasing Information Record and Source List, Generation of Purchase Order For Inventory and Consumables SOP List Incoming Goods This SOP contains step by step instruction on condition of accepting incoming goods in the warehouse, „booking In‟ procedure of component and non component goods, how to complete movements of incoming goods into different storage locations within the warehouse maintaining full traceability. Here you will find generation and filing of documents related to receipt of incoming goods. In-coming Raw Material and Components Handling This procedure describes quarantining, sampling, testing and releasing of incoming raw materials to Production. Here you will find the labeling requirement for component to be sampled, checking requirements of components, sampling and re-sampling of incoming goods for laboratory testing, generation of documentation during the movement of components in order to maintain complete traceability. Processing Issues Return and Rejects This SOP contains step by step instruction on issue of tested and QC released components for batch production, documentation needed for capturing identification and traceability information during the picking, assembling and transferring of those components from warehouse to production. This procedure also has instruction to follow during the return and reject processing of raw materials and components from production to warehouse. Dispatch of Goods from Warehouse This SOP contains instruction and documentation on movement of finished goods to quarantine until release for sale, dispatching procedure and documentation needed for transferring of finished goods from quarantine to warehouse store and subsequently to out side the manufacturing site maintaining a complete traceability of finished goods. Inventory Management In this procedure you will find a complete inventory management system by stock counting instruction, stock classification and reconciliation programs. Here you will find

instruction on cycle counting by material code, counting by bin sheet information and reconciling/cross checking of those counts by physical counting of the stock, determination of material gain or loss and filing instruction. Warehouse Locations and Storage Area This SOP is designed to understand and draw an schematic diagram of ideal warehouse and production areas, identifying in-coming goods storage unit types and storage bin types, quarantines, reject cage, cool room, flammable storage, dispensary booths, production area, finished goods quarantine area and finished goods storage areas. This procedure defines how storage unit types and storage bins are numbered. This SOP is to be used as a guide to define the types of storage units and bins, movement direction within the warehouse and production areas. Finished Goods Transfers to areas This simple SOP contains instruction and documentation on movement of finished goods from production to warehouse finished goods quarantine location until the samples are tested and released by the authorized persons. Sampling of Raw Materials This procedure primarily concerned with risk associated with sampling, precaution to be followed when sampling, general sampling procedures for raw materials, critical and non critical components, chemicals and secondary reference standards for laboratory. Sampling of Components and Printed Materials This procedure is an elaboration of SOP WAR-045 and mainly concerned with sampling plans and instructions of components and printed materials for quality testing before release for production use. Work in Progress This simple procedure describes the construction and locations of different work in progress areas between production and warehouse for temporary storage of raw materials, component and finished goods. Warehouse Racking This SOP outlines the measures to be taken to ensure the safety of all goods and personnel when using the storage racking system in order to avoid injury to staff or damage to property. This procedure concerned with the handling and storage of materials or products and to report any damage which may be occurred. This SOP particularly relates to the activities of the staff of the receiving and distribution warehouse. Forklift Operation in Warehouse This SOP gives instructions on operation requirements and maintenance of forklifts used in the warehouse, safety precaution to be taken during the operation of forklift under load.

Dispensary Procedure This procedure is mainly concerned with dispensing plans and instructions of released raw materials for production use. An example of tablet dispensary procedure is prepared for better explanation and understandings of dispensing. You will be able to follow the instruction for dispensing of any raw materials in your facility. Material Purchasing Information Record This simple procedure describes how to keep purchasing information for approved materials, vendors, manufacturers, standard and current pricing and third party agreements. Generation of Purchase Order This procedure describes the steps to be followed by planning and procurement department to create purchase order for inventory items to be purchased from overseas and local suppliers.

Quality Guidance Validation of Analytical Test Methods This guideline provides guidance for the validation of analytical test methods. These analytical test methods include those tests which evaluate API, Raw Materials, In Process samples (e.g. reaction monitoring) and early intermediate materials (prior to the introduction of the first critical intermediate). This also include Risk Assessment and Prioritization, System Suitability, Precision and Accuracy, Quantitation and Detection Limit Linearity, Range and Specificity, Robustness, Calculations of Residue Limits for Drug Product for Equipment Cleaning This guideline provides equations and examples for calculating the Maximum Allowable Residue and Residue Acceptability Limits for Drug Products and Non-Therapeutics. Examples are provided for determining the acceptable equipment cleaning residue limits for therapeutic drug products and for non-therapeutic ingredients. Swab Sampling for API Equipment This guidance provides recommendations related to the selection and application of swab sampling and visual inspection for various types of API equipment. Product and Equipment Grouping and Worst - Case Product Selection This procedure defines the criteria that should be considered when grouping Active Pharmaceutical Ingredient (API) and Drug Product (DP) equipment or product for the purposes of cleaning validation. Validation of Test Method for Rinsate and Swab Sample The guidance describes recommended approaches to develop and validate sampling and test methods for cleaning verification using rinse and swab samples. Visual Inspection and Quantitation in Equipment Cleaning Visual inspection is the minimum requirement for all clean and test regimes required for Cleaning and Cleaning Validation. Five aspects of visual inspection discussed in this guidance. Which are visual inspection following or during manual cleaning; visual inspection of dedicated equipment; routine visual inspection of multi-purpose equipment; visual inspection during validation and Visual Quantitation Documentation and Instruction in Cleaning Validation This guidance addresses recommendations for developing and documenting the rationale to support the product contact equipment cleaning program and to justify the validation strategy. This documentation may be described as a Cleaning Evaluation Report. Critical Process Parameters for Drug Product This guidance provides recommendations and examples for evaluating a process to identify and define the critical process parameters.

Identification of the Critical Steps for Drug Manufacturing Process This guidance provides recommendations for selecting critical process parameters and critical process steps based on the understanding of a drug product process. Equipment Cleaning Validation for API This procedure provides guidance in the validation of cleaning processes for equipment used in the manufacture of Active Pharmaceutical Ingredients (API). Equivalence Criteria of Impurities in API Process Validation This guidance provides recommendations for demonstrating equivalence of impurities to historic batches during validation of API processes for small molecules. Equivalency Comparison of Drug Product This guidance addresses the equivalency comparison of manufacturing process data from drug product (DP) validation batches to previous batches (called “reference” batches), when applicable. Calculation of Clean Equipment Hold Times This guidance describes considerations and risks for determining if the establishment of clean equipment hold times for equipment producing drug product and Active Pharmaceutical Ingredients (API) are required Evaluation of Non-cleaned Equipment Hold Time This guidance outlines considerations and risks associated with hold times between equipment use and cleaning. The recommendations to evaluate if the time between equipment use and cleaning needs to be established and controlled are described for Active Pharmaceutical Ingredients (APIs) and Drug Products. When they are determined to be critical, recommendations on how to establish and extend existing hold times are also described. Potential Impact of Changes in Process Validation This guidance provides recommendations and examples for evaluating the process validation impact of changes to manufacturing processes used for manufacture of API, Drug Products and packaging processes. Process Validation Sampling This guidance addresses recommendations for good sampling practices. Validation sampling plans must be specified or referenced in the protocol. Determination of Swab & Visual Inspection Sampling Locations This guidance provides recommendations related to the selection and application of swab sampling and visual inspection for various types of Drug Product equipment. Bulk Drug Product Holding Times This Guidance sets out guidelines for the determination and validation of in-process and bulk product holding times.

Demonstration of Active Pharmaceutical Ingredient (API) Batch Homogeneity This guidance provides information on demonstrating batch homogeneity of final APIs (small and large molecules) and critical intermediates.This procedure provides guidance for performing a homogeneity evaluation in support of API process validation. The following components of the evaluation are described: Materials to be tested, Selection of test methods for examining homogeneity, Sampling plan – when to collect samples, from what locations, and the number of samples, Selecting acceptance criteria for evaluating homogeneity test results. Continuous Quality Verification This guidance provides an example of documentation to support the use of Continuous Quality Verification for demonstrating that a manufacturing process is in a validated state. Supporting Documentation for Continuous Quality Verification This guidance describes the documentation needed to support the use of Continuous Quality Verification to demonstrate that a drug product or active pharmaceutical ingredient process is in a validated state. It also describes some similarities and differences between Continuous Quality Verification and traditional process validation using three discrete lots. Dose & Toxicity Data for Cleaning Limit Calculation This guidance provides points to consider when selecting Dosage and Toxicity data for use in the Cleaning Limits calculations. Inspection Attributes in Non Sterile Packaging Validation This procedure provides examples and guidance on classification of defects for packaged non-sterile drug products. Laboratory Instrument Qualification This procedure provides guidance in the qualification of simple, moderate, and complex laboratory equipment that is used in an analytical laboratory in a Good Manufacturing Practices (GMP) environment associated with products in or intended for the market place. Matrices and Bracketing in Process Validation Bracketing and matrixing allow a „most appropriate challenge‟ condition to be defined for a process or drug product family (the same drug product with different dosage strengths). This risk-based approach can allow the validation to be focused on the most challenging circumstances, or “worst cases.” Use of this approach can provide a significant benefit to reduce the overall validation effort. Considerations for Selecting Packaging Lot Sizes During Packaging Examples of primary and secondary packaging validation, both manual and automated operations are provided in this guidance. This also provides guidance on aspects to

consider for packaging validation. Explanations of factors to consider for acceptable packaging validation and lot size are provided with various practical examples. Non-Sterile Active Pharmaceutical Ingredient (API) Manufacturing Area This guidance is to address environmental control for existing, new, and modified nonsterile API processing areas used for the manufacture of commercial materials. This includes non-sterile API manufacturing areas where the API will subsequently be used to produce sterile Drug Product. Potential Critical Process Parameters and Validation Practices This Guidance provides a tabulation of potential critical process parameters and quality attributes of typical steps of primary solid drug product (i.e. dry products) packaging processes. It also includes packaging validation items such as evaluation of equipment, protocol and report contents, amount of data (e.g. number of runs) and if warranted, microbiological studies. Process Validation Sampling for Non-Sterile Liquid Semi Solid Drug Products This guidance provides Process Validation Sampling guidelines for non-sterile liquid (solutions and suspensions) and semi-solid (ointments, creams, pastes, gels and lotions) drug product dosage forms. Process Validation Sampling for Non-Sterile Solid Dose Drug Products This guidance provides Process Validation Sampling guidelines for non-sterile solid dose drug product dosage forms. The purpose of this guidance is to provide the general principles and approaches that should be considered for sampling non-sterile solid dosage forms. Performance Qualification Versus Process Validation This guidance compares and contrasts Performance Qualification (PQ) to Process Validation (PV). This guidance describes the differences between PQ and PV. It clarifies how the PQ term is applied to systems and to processes. As applied to processes, PQ batches are used to demonstrate the robustness of a process and PV batches are intended to demonstrate the reproducibility of the process. As applied to systems, PQ testing is intended to verify that integrated systems function together as required Periodic Review of Processes and Systems This guidance addresses the application of a risk-based approach to: Prioritize the systems and processes for periodic review (PR); Justify frequency and schedule of PR (if applicable); Routine revalidation of processes. Release of Drug Product and API Pre-Validation and Validation Batches For Commercial Use This guidance addresses considerations for commercial release of batches of product manufactured prior to completion of process validation (PV) activities, and considerations for release of batches associated with performance qualification (PQ) and PV activities.

Selection of Critical Process Parameters for Validation This guidance discusses the term critical process parameter and considerations are described for identifying the term CPP that need validation. It is applicable to the manufacture of commercial intermediates, API, Drug Products and packaging. Critical Process Parameters for Semi-Solid Dosage Forms This guidance provides an explanation of the semi-solid Drug Product dosage form and recommendations for analysis of the manufacturing process critical process parameters. Semi-solids come in a variety of dosage forms, yet significant steps and equipment used for the manufacturing processes share commonality. The critical process parameters will often be the same from process to process. Potential Critical Process Parameters Solid Oral Dosage Forms This guidance provides an overview of potential critical process parameters for the manufacturing of solid oral dosage forms. Solid oral drug products come in a variety of dosage forms frequently with common steps and equipment. The potential critical process parameters are often the same from process to process. This guidance provides an overview of process steps and typical equipment involved in manufacturing of solid oral dosage products and notes what might be critical process parameters associated with these process steps and equipment. Solvent Recovery Validation Example This guidance provides an example of the documentation for validation of a solvent recovery process. Solvent recovery validation is needed in some situations such as where the recovered solvent is intended for general site wide reuse into suitable manufacturing processes, including other API manufacturing processes than those from which the used solvent originated Test Deviations During Validation Out-of-specification (OOS) results and any other deviations that may impact the acceptability of the qualification/validation should be documented, investigated, root cause determined, corrective action taken and reported. Several examples are included. Validation Activities During Technology Transfers This document provides guidance for qualification and validation activities that take place as a result of the Technology Transfer for approved commercial Active Pharmaceutical Ingredient (API) and Drug Produc processes. Other aspects of Tech transfers such as regulatory changes, stability impact, etc must also be considered as described in relevant guidance, but these other activities are outside the scope of this guidance. Validation Considerations for Re-work and Re-process of Active Pharmaceutical Ingredients This document provides guidance to determine if validation of re-work and/or reprocessing steps are required for Active Pharmaceutical Ingredient (API) processes.

This guidance provides recommendations for evaluating the potential impact on product quality to determine if a given re-work or re-process step requires validation Validation Documentation This guidance provides recommendations for the content of the planning, testing and reporting types of validation documentation. Shipping Validation for Biopharmaceutical Materials The risk of compromising biopharmaceutical materials in shipping is relatively high, as these materials are particularly vulnerable to degradation when exposed to various environmental and handling conditions. The risks can be managed effectively through qualification of packaging, handling, and transport procedures. System Level Impact Assessment for Information Systems This document explains how the Commissioning and Qualification System Level Impact Assessment template can be used for Information Systems. To classify Information Systems as Direct, Indirect or No impact systems, only one question is applicable for Information Systems. By means of three typical examples, this guidance explains how system classification could be performed, based on the use of the system and its data. Clean Pure Steam System Commissioning , Qualification and Sampling Plans This document recommends sampling locations, frequencies and testing activities associated with the commissioning and qualification of new installations or major revisions of Clean/Pure Steam Systems (e.g. the addition of new subloops or other system wide retrofitting). This guidance defines the sampling location, frequency, and testing activities utilizing a risk based approach for supporting the commissioning and qualification for a clean/pure steam system. Product Quality Complaint Handling This Complaint Handling guidance defines practices for establishing and maintaining a product quality complaint handling system, and for monitoring and reporting corrective actions based on the findings Application of Quality Risk Management to Periodic Review of SOPs Application of Quality Risk Management to Periodic Review of SOPs is intended to provide a tool for determining the optimal review frequency that will ensure those SOPs which relate to GMP systems or processes and therefore bear the greatest potential for impact on product quality are reviewed/revised in a timely and possibly more frequent manner than those which are determined to be less critical or reflect stable processes. Statistical Rationale for Raw Material Sampling The practice of using the √N+1 as a rule for sample size is common in the pharmaceutical industry. Quality Risk Management Application for Critical Instrument Calibration

This document offers a risk assessment approach to document a critical instrument calibration interval change request. Structured On-the-Job Training System This document discusses considerations for a site Structured On-the-Job Training system including GMP tasks and knowledge necessary to perform those tasks. Training system for Aseptic and Preparation forAseptic Operators and Support Staff This document discusses considerations for a robust training system for those working in or in support of a preparation for aseptic processing area. Disposal of Rejected and Waste Materials This document provides guidance for the handling, collecting and disposing of waste materials. Quality Assurance Audit This document provides guidance in the conduct of Quality Assurance Audits to verify and assure the effectiveness of on-going quality systems, practices and programs and to identify potential procedural gaps or system weaknesses at Manufacturing Production and logistic Sites. Annual Product Records Review This document provides guidance in the performance of annual product record reviews to evaluate data and trending to: Verify consistency of the process; Identify the need to modify specifications, and Identify any preventive or corrective actions that would lead to product quality improvements. Receipt, Approval and Use of Labels and Labeling This document provides guidance on the printing, receipt, storage, use and reconciliation of product labels and labeling for active pharmaceutical ingredients (API), medical devices, and drug products. Weighing and Measuring Practices In Manufacturing Operations This document provides guidance in the weighing and measuring of materials used in the manufacture of drug products, active pharmaceutical ingredients (API), medical devices, and intermediates. Material Supplier Approval This document provides guidance in the process for identifying suppliers to be audited and the process for conducting and documenting such audits and approving suppliers. Storage & Distribution of Drug Products and Medical Devices This document provides guidance the storage and distribution requirements for Drug Products, Medical Devices and related Production Materials from a GMP Site or Logistics Centers, and/or transported between manufacturing and Logistic Sites.

Control of Manufacturing and Packaging Defects Non Sterile This document provides guidance on the inspection of non-sterile drug products and non-sterile medical devices for manufacturing and packaging defects. Pest Control This document provides guidance in the implementation and maintenance of pest control program for buildings and facilities at a GMP Site and Logistics Centers that are used for production, testing, or storage of pharmaceutical ingredients. Receipt and Storage of Raw Materials and Packaging Materials This document provides guidance for receipt and storage of raw materials (RM), components, and packaging materials used in the manufacture and packaging of active pharmaceutical ingredients (API), drug products, and medical devices. Sampling of Production Materials and Finished Goods This document provides guidance for a sampling program for Raw Materials (RM), Starting Materials, Packaging Materials, Labeling, In-Process Materials, Intermediates, Active Pharmaceutical Ingredients (API), Drug Products, Biologics, Medical Devices, Medical Device Components and Materials with Direct or Potential Product Contact. Water Purification, Storage and Distribution for Pharmaceutical Production This document provides guidance for the purification, storage and distribution of water used for Production including water used for cleaning of product contact equipment, containers, and closures. Use of a Risk-Based Approach To Establish External Quality Assurance Audit Frequency The purpose of this document is to provide guidance for GMP Quality Audits stakeholder‟s responsibility to utilize a risk-based approach for determining External Quality Assurance Audit prioritization and frequencies. Reduced Testing Program This guidance document defines a science and risk-based approach for the evaluation and implementation of a reduced testing program for the release of starting materials, intermediates, APIs, excipients and packaging components at a GMP user site upon receipt from vendors (manufacturer/supplier). The guidance also provides an example of the application of Quality Risk Management principles in the implementation of a reduced testing program. GMP Training System This document discusses considerations for site GMP Training systems including training on regulations, GMP concepts, GMP tasks and knowledge necessary to perform those tasks. Stability Testing

This document provides guidance for the stability testing for drug products, consumer non-drug products (e.g., cosmetics), Active Pharmaceutical Ingredients (API), API Intermediates for Sale and medical devices manufactured at GMP facilities. Quality Risk Management application to identify Deviations vs. Events Often times, deviations that occur during the handling, manufacturing, testing or distribution of materials/products have little or no impact on product quality or to its registration filing. The purpose of this guidance is to provide a process for assessing if a deviation does or does not impact the product quality or its filing through the use of a Quality Risk management tool. Implementation of Real Time Release This document provides practical guidance on how to implement a Real Time Release (RTR) testing approach as part of a manufacturing control strategy to ensure product quality while enabling the rapid release of API, intermediate and/or finished products. Preventive Maintenance This document provides guidance in for Preventive Maintenance of direct impact systems and associated critical components used in production, storage, and testing that may affect the safety, identity, strength, quality, or purity of active pharmaceutical ingredients, drug products, drug product raw materials, API starting materials, critical inprocess materials, critical intermediates, biologics, or medical devices. Calibration This document provides guidance for the calibration of equipment, instruments, and standards used in production, storage and testing that may affect the identity, strength, quality or purity of Pharmaceutical drug products, active pharmaceutical ingredients and medical devices. Determining Testing Patterns and Acceptance Criteria for Analytical Method Transfers This document provides guidance for setting experimental testing patterns and acceptance criteria for Analytical Method Transfer Exercises. This document provides guidance to GLP sites in identifying lots and number of samples for testing, setting appropriate acceptance criteria for conducting transfers. Quality Risk Management Application to Establishment of Weighing Device Performance Testing Intervals Application of Quality Risk Management to performance checks for weighing devices such as balances and scales is intended to provide a tool for determining the acceptability of decreasing the frequency of verifying the performance of a weighing device from the current frequency (e.g. daily) to an alternative schedule. Analytical Laboratory Management This document provides guidance for the management of analytical laboratories including the following: Personnel training; Proper handling of samples; Hazardous

materials; Control and maintenance of reagents, reference standards, and buffers; Laboratory facilities and equipment; and Documentation and control of test results. Microbiology Laboratory Management This document provides guidance for the management of microbiology laboratories including the following: Proper handling of samples; Control and maintenance of reagents, reference standards, buffers, microbial cultures, and microbiological culture media; Monitoring and control of the microbiology laboratory environment; Calibration and maintenance of laboratory equipment; and Documentation and control of microbiological test results. Transfer of Analytical Methods This document provides guidance for establishing a documented process for the transfer of analytical methods, microbiological and/or bioanalytical methods. Quality Agreements This document provides general guidance to site Quality Teams responsible for writing, revision and maintenance of Quality Agreements with suppliers of materials. Clean Steam Systems This document provides guidance for clean steam used in aseptic applications, and applications where the steam or condensate directly contacts products or materials, or direct product contact surfaces (i.e., equipment, containers, closures). Cleaning and Sterilization of Aseptic Manufacturing Equipment This document provides guidance in the cleaning and sterilization of aseptic manufacturing equipment to minimize the risk of particulate and microbiological contamination. Container Closure Integrity for Sterile Drug Products This document provides guidance for ensuring that the integrity of the container closure system will protect the product over its shelf life. Controlling the Microbiological Quality of Solid Oral Dosage Forms To control the microbial quality of a non-sterile Solid Oral Dosage form, it is recommended to perform a risk assessment of the manufacturing process to identify potential sources of microbial contamination. The intention of this document is to provide guidance to determine and control these sources of microbial contamination. Defining Worst Case Conditions for Aseptic Process Simulations Aseptic process simulation tests (e.g. media fills) “are used extensively and are recognized as an effective way to validate aseptic filling” processes for the purpose of complying with regulatory GMP expectations. A media fill begins at the point where the final sterilization of the product takes place (i.e. where aseptic operations are performed) through the completion of filling operations with the sealing of the filled containers.

Evaluation of Repeat Testing and Retesting During Microbiological OOS Investigation During a laboratory investigation, confusion may arise as to the difference between these terms and their overall purpose. This document provides a more detailed explanation of these differences and the individual importance of these tools during a microbiological OOS laboratory investigation. In addition, this guidance will also briefly clarify similarities and differences of these definitions as compared to analytical OOS laboratory investigations. Gamma Radiation Sterilization This document provides guidance for validation of gamma radiation sterilization processes used to sterilize active pharmaceutical ingredients, drug products, medical devices and non-product items, such as, APA gowning articles, containers, and closures with direct or potential contact with sterile raw materials, APIs, drug products or medical devices. Microbial Attributes Testing of Non-Sterile Solid Oral Dosage Forms and Materials The intention of this document is to provide guidance to determine the need for performing microbial attributes testing of drug product raw materials, non-sterile excipients, active pharmaceutical ingredients and finished drug products. This guidance is recommended in order to ensure the microbiological quality of any non-sterile solid oral dosage form. Microbiological Testing in Cleaning Validation This document describes the rationale and recommended microbiological methodology for consideration during cleaning validation of product contact surfaces for Active Pharmaceutical Ingredients and drug products. Overview of Trending of Environmental Monitoring Data This guidance establishes the need for trending of environmental monitoring data and gives recommendations on aspects of trending such as categorization of data, frequency of trending, trend definition, and content of trend reports. Packaging System Integrity for Sterile Medical Devices This document provides guidance for determining the suitability of packaging materials and the evaluation and testing of the integrity of packaging systems for sterile Medical Devices manufactured and/or packaged by GMP sites. Cross Contamination Prevention This document provides guidance for the prevention of cross contamination in production processes, warehousing, material transfer, and distribution. Prevention and Control of Fungal Contamination in Tablets What steps can be taken to prevent and control of fungal contamination in tablets? The presence of water is the key element in the growth of fungal contamination. This document discusses the prevention and control of fungal contamination in tablets

production to include: raw material and API testing, manufacturing processes, environmental monitoring, and final product testing. Sanitant Rotation in a Routine Sanitization Program What are the expectations for industry for the inclusion of different sanitization agents within a routine sanitization program? Additionally, are there tangible benefits to routinely rotating sanitization agents? Finally, how is sanitant performance defined? Sterilization/Depyrogenation Validation for Equipments and Containers This procedure provides guidance for validating sterilization and depyrogenation of equipment and containers and closures with direct or potential contact with sterile medical devices, sterile drug products or sterile active pharmaceutical ingredients. Unplanned Cleanroom Power Outage Time Limit and Recovery How can the time between a cleanroom power outage and loss of environmental control in the critical area be determined? Once the power is restored, how can the time it takes to recover the desired environmental conditions be determined? An interruption of power supply to the HVAC systems may produce a “loss of control” which can be defined as a breech in the integrity of the controlled areas in sterile manufacturing. Appropriate steps to be taken during and after an interruption of air supply to the aseptic processing area. Use of Sterilized Goggles Within the Aseptic Processing Area This document will discuss the requirement for goggle use within Aseptic Processing Areas (APA) as well as products and processes that are available to assist sites in complying with established requirements. Suggested elements of a sterile goggle program are also considered. Water Activity in Pharmaceutical Manufacturing This document discusses the basic principles of water activity and the importance it has in the manufacture of pharmaceuticals. It also provides direction on when and where testing for water activity can be most beneficial.

Quality Manuals Evaluation of Contaminant Options for Packing of Solid Dosage Forms This guideline is designed to assist decisions on how to appropriately accommodate the packing of solid dosage forms starting from bulk-packed tablet product through to the finished pack for shipping. The focus of this document is on the technical issues that must be addressed. Retention and Disposal of GMP Documents and Retention Samples The purpose of this procedure is to describe the minimum requirements for the retention of samples and documents under GMP and Medical Device regulations/legislation. Local legislative and regulatory requirements which may require retention of increased sample quantities or longer retention periods, take precedence over this procedure. Certificate of Materials Supplied This guideline aims to define the processes for certification of materials provided by suppliers including the requirements for maintaining materials in a “certified“ status for use. Quality Agreements The purpose of this Guideline is to define the general requirements and provide guidance for Quality Agreements for the development, manufacture, testing, storage and distribution of intermediates, active pharmaceutical ingredients and investigational products destined for use in pre-clinical, clinical and other Research and Development studies. Procedure for Quality Assurance Management for Contractors The purpose of this Procedure is to describe the requirements for the quality management of contractors; to describe the role of contract giver sites in this context and to provide a model for the development of Quality Assurance Agreements with Contractors Regulatory Inspection Guideline To provide the minimum mandatory requirements for notification, conduct, reporting and follow-up action associated with inspections by regulatory authorities and also to outline recommendations on how to achieve compliance. Quality and Compliance Auditing The purpose of this guideline is to define the concept of Quality and Compliance Auditing within the system of quality management and outline the roles and responsibilities for planning, performing, reporting and follow-up of audits. Auditor Training To provide minimum mandatory requirements and outline best practice for ensuring that company auditors have a common baseline of training and experience in order to carry

out GMP Quality and Compliance Audits of company suppliers and internal audits of their own sites. Compliance Improvements Plans for GMP Facility The purpose of this document is to provide some requirements as well as some recommendations for the development, content and management of Compliance Improvement Plans (CIPs). Archiving, Disposal and Record Management Guideline The purpose of this document is to provide management and technical personnel with requirements as well as guidance on the archiving, records management and disposal of data and information. Internal Quality Assurance Agreements The purpose of this procedure is to describe the process for Quality Assurance (QA) Agreement regarding the supply of active pharmaceutical ingredients, bulk formulated products, part finished packs and finished packs to be followed by a pharmaceutical operation. Audit of a Distribution Site This Procedure defines the procedure for performing Distribution Site audits and includes selecting, preparing for, conducting, reporting and documentation archiving of Distribution Site audits. Supplier Auditing for GMP Facility This manual is to provide guidance on assigning Lead Audit Team/Site responsibilities, establishing an external supplier‟s audit program, and the high level principles involved inconducting supplier audits. Management of Master GMP Document The purpose of this Guideline is to provide the regulatory requirements for the management of master GMP documents; issued, controlled and used to verify compliance with required codes of GMP and/or other relevant Quality and Compliance Standards. Recommendations are also included on how to achieve compliance Artwork Creation & Control of Printed Packaging Components The purpose of this Guideline is to describe the way in which artworks and printed package components should be created and controlled. Computerized Systems Risk Management To define the requirements for the application of risk management principles to computerized systems. Cross Contamination Risk Evaluation Process for Commercial Compounds The purpose of this Guideline is to describe the process in place to ensure that drug products and drug substances are manufactured in a manner that minimizes patient risk

through adulteration from products manufactured in the same manufacturing plant or facility. Certificate of Analysis & Certificate of Manufacture The purpose of this guideline is to define the content of Batch Specific Documentation (BSD), the process by which BSD is produced and the use to which it is put. BSD in this context refers to the Certificate of Analysis, (CofA) and the Certificate of Manufacture (CofM). Annual Product Reviews & Product Quality Reviews The purpose of this Guideline is to provide requirements for the content, scope and procedures for developing Annual Product Reviews and Product Quality Reviews, and also to outline recommendations on how to achieve compliance. Warehousing and Distribution of Commercial Products The purpose of this Guideline is to provide guidance on the warehousing and distribution of commercial products. Utility Standards The purpose of this Guideline is to provide guidance on the design and specification of utilities associated with the manufacture, quality control and storage of API, intermediates and investigational products within an R&D facility. Conducting Investigations To provide requirements in addition to recommendations for the performance of investigations in response to an incident, problem or deviation that may affect the safety, identity, strength, purity or quality of an active pharmaceutical ingredient (API) or drug product. Management and Documentation of Training To provide requirements for management and documentation of training and also to outline recommendations on how the requirements can be met. Definition and Documentation of Raw Data The purpose of this Guideline is to provide requirements in the definition and documentation of raw data and also to outline recommendations on how to achieve compliance. Conducting Investigations in a GMP Site To provide requirements in addition to recommendations for the performance of investigations in response to an incident, problem or deviation that may affect the safety, identity, strength, purity or quality of an active pharmaceutical ingredient (API) or drug product. Management and Documentation of Training

To provide requirements for management and documentation of training and also to outline recommendations on how the requirements can be met. Risk Management in the Quality Assurance and Compliance Area The purpose of this document is to give guidance on a process for risk identification, assessment, control and review within the area of GxP regulated quality and compliance. Guideline for Development and Contents of Specifications The purpose of this guideline is to describe the process for generation, approval and management within R&D of specifications for release of materials used in clinical trials during drug development. It also gives guidance on the contents of such specifications for drug substance, several common types of investigational medicinal products and excipients. Determination of Storage Periods for APIs, Excipients, Intermediates and Raw Materials The purpose of this Procedure is to define the requirements for the retesting and assignment of storage periods for API‟s, excipients, intermediates and raw materials. The Preparation of Process Validation Master Plan This procedure covers the planning of validation activities related to the manufacturing and control of the registered stages of Drug Product or Active Pharmaceutical Ingredient (API) for clinical use, validation or sale. Process Validation of Bulk Medicinal (API and Intermediate) The purpose of this document is to provide guidance on the validation of processes for the manufacture of bulk drug i.e. those synthetic stages from introduction of the defined API Starting Materials into the process up to and including the physical processing of the API (Active Pharmaceutical Ingredient). Validation should extend to those operations determined to be critical to the quality and purity of the API. The validation of stages prior to the API Starting Materials is not mandatory. A risk assessment may deem it necessary. Process Validation for Formulated Products The purpose of this document is to provide minimum mandatory requirements in the validation of processes for the commercial manufacture of formulated products to demonstrate the effectiveness and reproducibility of a process and being suitable for the intended purpose. The purpose is also to outline recommendation on how to achieve compliance. Cleaning and Cleaning Validation of API Plant and Equipment The purpose of this guideline is: To define the requirements for cleaning plant and equipment used to manufacture active pharmaceutical ingredients (APIs) or their intermediates; To give guidance on how to assure appropriate cleaning of API plants and equipment; To describe when validation is applicable and what must be done to complete validation.

Cleaning and Cleaning Validation For Formulated Products The Purpose of this guideline is to define the minimum requirements for cleaning and validation of cleaning processes for formulated product. It also covers post validation monitoring of the effectiveness of cleaning processes. Sterilization Process Validation To provide guidelines for the validation of sterilization processes used in the manufacturing activities for drug products or active Pharmaceutical ingredients (API) and also to outline recommendations on how to achieve compliance. Analytical Laboratory Procedure Validation The purpose of this guideline is to outline the content and approval process for analytical procedures, and to describe those activities that should be carried out to demonstrate that analytical procedures used in laboratories within R&D and manufacturing operations are suitable for their intended purpose. Water Quality Standard To describe the quality standards required for the production, distribution, use and testing of water used in the manufacture of manufactured materials. Sterility Testing Procedure The purpose of this Guideline is to provide a general guideline for sterility testing. This guideline should aid in assuring that the products manufactured at the company‟s sites as well as by a contract manufacturers meet the appropriate regulatory and company requirements and that there is a harmonized, company-wide approach to the concept of sterility testing. Storage and Expiry Dating of Analytical Reagents in Laboratory The purpose of this Guideline is to outline the requirements in the expiration dating of all analytical reagents and solutions prepared from these reagents. Recommendations are also included on how to achieve compliance. Preparation & Maintenance of Stability Protocols and Stability Master Plans The purpose of this document is to describe the procedure for the preparation and management of Stability Protocols and Stability Master Plans for marketed products and Drug Substances. Microbiological Testing for Non Sterile Medicinal Product The purpose of this Guideline is to provide guidance for the microbiological testing of non-sterile products. This guideline should aid in assuring that the products manufactured at each of the gmp sites as well as by a contract manufacturer should meet the appropriate regulatory and company requirements and that there is a standardized, company-wide approach to the basic concept of microbiological quality control of non-sterile products.

Reference & Retention Samples The purpose of this guideline is to describe the requirements for the sampling and storage of reference and retention samples under GMP regulations/legislation. Local regulatory requirements that require the retention of additional samples, increased sample quantities or longer retention periods, take precedence over this guideline. Commercial Stability Testing For Formulated Products The intent of this procedure is to provide to manufacturing and primary packaging sites the principles of a stability program. Environmental Monitoring The purpose of this Guideline is to provide requirements for environmental monitoring. This guideline provides recommendations on how to achieve compliance with the requirements. This guideline will aid in assuring that the commercial and investigational medicinal products manufactured will meet the appropriate regulatory and company requirements. Trending of Stability Data The purpose of this international guideline is to outline minimum mandatory requirements as well as recommendations for the identification and reaction to trends found in stability data Manufacturing Documentation This document provides guidelines for the way in which the commercial manufacture and packaging of Active Pharmaceutical Ingredients (API) and formulated drug products should be documented. Maintenance and Calibration of GMP Critical Items in Manufacturing Operations The purpose of this guideline is to define the general requirements and to provide guidance for the calibration and maintenance of instruments, equipment, facilities, utilities/services and systems. Re-treatment and Blending of API & Formulated Product The purpose of this guideline is to provide guidance regarding the reworking, reprocessing or recovery (salvaging) of formulated products, active pharmaceutical ingredients (API‟s) and intermediates used in the processing of APIs. In-Process Testing, Checks and Sampling The purpose of this International Guideline is to describe the requirements for inprocess testing and sampling during manufacture and packing. Management of Returned Goods The purpose of this International Guideline is to describe the principle of handling the quality assessment and recovery of returned goods. Management of Change in Manufacturing Operations

The purpose of this procedure is to define the principles for management of change within Operations. This document may applies to the Change Management process, to Regulatory Affairs, CMC and to all cGMP activities performed by an Operation sites. It applies to all facilities, processes, systems and procedures used during manufacture, testing and distribution that may directly or indirectly affect the quality of pharmaceuticals products. . The Validation of Facilities and Systems The purpose of this guideline is to provide requirements for the Validation of Facilities and Systems and to outline recommendations on how to achieve compliance. Information Technology Infrastructure Qualification This Guideline provides guidance on the qualification requirements to be applied to the Information Technology infrastructure. The establishment and maintenance of a qualified infrastructure for any regulated company is fundamental to meeting current business and regulatory requirements in respect of systems stability, reliability and security. Management of Change in Computerized System The purpose of this Guideline is to define and provide guidance on the requirements for managing and documenting changes which take place during the development, implementation or operation of a computerized system, including its supporting operating environment. Access by Regulatory Authorities and Auditors to Electronic Records The purpose of this Guideline is to advise on the practices to be adopted when wishing or requested, to display or provide copies of electronic records to regulatory authorities, auditors and other similar third parties. Guidelines for Generating Manufacturing Documentations This document provides guidelines for the way in which the commercial manufacture and packaging of Active Pharmaceutical Ingredients (API) and formulated drug products should be documented. Electronic Records and Electronic Signatures The purpose of this document is to provide an interpretation of FDA 21 CFR Part 11, Electronic Records; Electronic Signatures (ER/ES) and to provide guidance for acceptable practices in the use of electronic records and electronic signatures by any site.

GMP Audit Auditing Principles for GMP Audit Apply the auditing techniques referenced in this unit to an actual audit. Understand the reasons for using these techniques, understand and use the auditing components while performing a GMP Audit. Use a range of information tools in support of a GMP Audit. Develop and communicate a complete audit agenda (may also be referred to as audit plan) both to audit team members and the firm/area being audited. Effectively execute an audit agenda, Use generally accepted auditing techniques to conduct the audit. Document and communicate audit findings in a clear, concise report that includes examples of identified deficiencies. Understanding Worldwide Regulatory Requirements Determine the appropriate Worldwide Regulatory GMP requirements for a site or product being audited. Identify which Regulatory Agencies govern specific regions of the world. Use a range of information tools in support of a manufactured product distributed and sold throughout the world. Recognize compliance or non-compliance of Worldwide Regulatory GMP requirements based upon the country or region audited. Explain what the relationships are among the Worldwide Regulatory GMP agencies. Personnel & Training System Audit Perform an audit of a personnel and training system. Know and understand which of the worldwide requirements apply to personnel and training. Use a range of information tools, including the contents of this module in support of a personnel and training audit. Recognize compliance or non-compliance of regulations pertaining to personnel training requirements. Deviation Management System Audit Perform an audit of a deviation management system. Use a range of tools and information, including the contents of this unit to support the audit of a deviation management system. Understand and apply appropriate GMP standards/regulations and In-house standards to an audit of a deviation management system. Recognize compliance or non-compliance of deviation management systems to applicable regulations Validation System Audit Perform an audit of a validation system (excluding computer systems). Use a range of tools and information, including the contents of this unit to support the audit of a validation system. Understand and apply appropriate GMP standards/regulations to an audit of a validation system. Recognize compliance or non-compliance of a validation system to applicable regulations Change Management System Audit Perform an audit of a change management system. Use a range of tools and information, including the contents of this unit and the internet to support the audit of a change management system. Understand and apply appropriate GMP standards/regulations to an audit of a change management system. Recognize

compliance or non-compliance of a change management system to applicable regulations. Complaint System Audit Perform an internal, supplier or contractor audit of a complaint system. Know and understand which of the worldwide requirements apply to managing complaints. Use a range of information tools, including the contents of this module and the Internet in support of a complaint audit. Recognize compliance or non-compliance to regulations pertaining to complaints. Documentation System Audit Perform an audit of a documentation system. Use a range of tools and information, including the contents of this unit to support the audit of a documentation system. Understand and apply appropriate GMP standards/regulations to an audit of a documentation system. Recognize compliance or non-compliance of documentation systems to applicable regulations. Calibration, Preventative Maintenance & Housekeeping System Audit Perform an audit of a calibration, preventive maintenance and housekeeping system. Use a range of tools and information, including the contents of this unit and the internet to support the audit of a calibration, preventive maintenance and housekeeping system. Understand and apply appropriate GMP standards/regulations to an audit of a calibration, preventive maintenance and housekeeping system. Recognize compliance or non-compliance of calibration, preventive maintenance and housekeeping systems to applicable regulations. Computerized Systems Audit Identify computer systems with GMP implications within the scope of the GMP facility audit Include in the audit an assessment of the computerized systems used to support a GMP facility. Understand and apply applicable GMP requirements to the audit. Recognize compliance or non-compliance of GMP facilities to applicable regulations for computerized systems. Utility Systems Audit Perform an audit of a site utilities system. Use a range of tools and information, including the contents of this unit and the Internet, in support of auditing a utilities system. Understand and apply applicable GMP standards to an audit of a utilities system recognize compliance or non-compliance of a utility system to applicable regulations. Warehouse and Distribution System Audit Perform an audit of warehousing and distribution. Access and understand warehousing and distribution requirements, including licensing requirements. Use a range of tools and information, including the contents of this module and the Internet, in support of auditing warehousing and distribution. Understand and apply applicable GMP standards/regulations to an audit of warehousing and distribution. Recognize

compliance or non-compliance of regulations pertaining to warehousing and distribution requirements. Environmental Monitoring System Audit Perform an Environmental Monitoring Audit. Use a range of tools and information, including the contents of this unit and the Intranet, to support an Environmental Monitoring Audit. Apply worldwide regulatory agency requirements to Environmental Monitoring. Recognize compliance or non-compliance of regulations regarding Environmental Monitoring requirements. Microbiology and Sterility Testing Laboratory Audit Understand what the GMP requirements are for microbiological and sterility testing laboratories. Identify which GMP regulations govern microbiological and sterility testing laboratories. Use a range of information tools, from the contents of this training module to the Intranet, in support of microbiological and sterility testing. Recognize compliance or non-compliance of a microbiological and sterility testing laboratories Analytical Quality & Stability Testing Laboratory Audit Understand what the GMP requirements are for the analytical quality laboratory and stability testing laboratory. Identify which GMP regulations govern the analytical quality laboratory. Use a range of information tools, from the contents of this training in support of analytical testing and stability testing auditing. Recognize compliance or noncompliance of analytical quality laboratory and stability testing. Material Handling System Audit Perform an audit of a material handling system. Use a range of tools and information, including the contents of this unit to support the audit of a material handling system. Understand and apply appropriate GMP standards/regulations to an audit of a material handling system. Recognize compliance or non-compliance of material handling systems to applicable regulations. Active API Manufacturer Audit Perform an audit of an API manufacturer. Use a range of tools and information, including the contents of this module and the Internet in support of auditing an API module. Understand and apply applicable GMP standards to an audit of an API manufacturer. Recognize compliance or non-compliance of API manufacturers to applicable regulations. Packaging Material Supplier Audit Perform a packaging component supplier audit. Understand which worldwide requirements apply to packaging component suppliers. Use a range of information tools, including the contents of this module, in support of a packaging component supplier audit. Recognize compliance or non-compliance with regulations pertaining to packaging component supplier‟s requirements. Packaging and Labeling Operation Audit

Perform a packaging and labeling audit. Know and understand which of the worldwide requirements apply to packaging and labeling operations. Use a range of information tools, including the contents of this module to the Intranet, in support of a packaging and labeling audit. Recognize compliance or non-compliance of regulations pertaining to packaging and labeling requirements. Aseptic Sterile Area Audit Perform an audit of an aseptic/sterile processing area. Access and understand aseptic/sterile manufacturing requirements. Understand worldwide regulatory agency requirements for aseptic/sterile processing. Use a range of information tools, from the contents of this module to the Intranet in support of an aseptic/sterile processing audit. Recognize compliance or non-compliance of areas to regulations pertaining to aseptic/sterile processing requirements. Auditing an Excipient Supplier Perform an audit of an excipient vendor. Use a range of tools and information, including the contents of this unit and the Internet, in support of auditing an excipient vendor. Understand and apply applicable GMP standards and site standards to an audit of an excipient vendor. Recognize compliance or non-compliance of excipient vendors to applicable regulations. Auditing an Oral Solid Solution Area Apply the regulatory requirements related to oral dosage forms. Perform an audit of oral dosage forms. Use a range of information tools, from the contents of this unit to the Intranet in support of an audit of oral dosage forms. Recognize compliance or noncompliance of regulations pertaining to requirements for oral dosage forms

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Good Industry Practices Facilities and Equipments Equipment Cleaning for Drug Products, Identification of Equipment Areas and Processes, Equipment Cleaning for Active Pharmaceutical Ingredients (APIs), Calibration Preventative Maintenance, Cleaning and Sterilization of Aseptic

Manufacturing Equipment, Areas and Facilities Cleaning and Maintenance, Pest Control, Water Purification, Storage, and Distribution for Pharmaceutical Production, Air Handling Systems & Air Classifications for Aseptic Operations, Clean Steam Systems, Aseptic Area Environmental Control Material Handling Reevaluation of Stored Materials, Disposal of rejected and waste material, Material Status Indication, Material Supplier Approval, Raw Materials and Packaging Materials – Receipt, Sampling of Production Materials and Finished Goods, Storage and Distribution of Drug Products, Medical Devices, and Related Materials, Subdividing Dispensing & Transferring Materials to Production Areas, Quarantine Shipment Packaging and Labeling Instructions for Filling, Labeling and Packaging Pharmaceutical Drug Products and API's for Commercial Purposes, Creation, Revision, and Approval for Artwork Used on Packaging Components, Receipt, Approval, and Use of Labels and Labeling, Container Closure Integrity for Sterile Drug Products, Packaging System Integrity for Sterile Medical Devices Operations Practices Inspecting for Manufacturing and Packaging Defects-Aseptic, Instructions for Manufacture of APIs and Drug Products, Uniform Practices for Manufacturing Operations, Personnel Qualification Program for Aseptic Processing Areas and Preparation for Aseptic Areas, Aseptic Processing Facility Environmental Monitoring, Use and Recovery of Solvents in API Manufacturing, Metal Detection, Weighing and Measuring Practices in Manufacturing Operations, Gamma Radiation Sterilization, Preventing Cross Contamination, Control of Manufacturing and Packaging Defects NonSterile, Sterilization/Depyrogenation Validation: Non-Product, Gowning Practices for Aseptic Processing Areas and Preparation for Aseptic Areas, Cleaning Depyrogenation and Sterilization of Containers and Closures, Sterilizing Filters and Filtration Systems, Moist Heat Terminal Sterilization of Aqueous Parenteral Products, Media Fills for Sterile Drug Products and Aseptically Processed Medical Devices, Batch and Lot Identification, Aseptic Manufacturing Practices Laboratory Practices Analytical Laboratory Investigations, Evaluation and Investigation of trace unidentified chromatographic peaks, Control of Foreign Matter, Testing and Inspection of Sterile Products, Laboratory Documentation, Laboratory Management, Microbiology Laboratory Investigations, Stability testing, Sterility and bacterial endotoxin testing, Sterility test isolators, Transfer of analytical methods, Use and Control of Laboratory Reagents and Reference Standards, Verification of compendial analytical methodology Quality Practices Batch Record and Device History Record Review, Deviation Reporting, Quality Risk Management, Medical Device Corrective & Preventative Action (CAPA), Device Master Record/Device History Record, Documentation Practices, Stop Distribution, Disposition

of Production Materials and Finished Products, Market Actions, Product Change Management, Quality Assessment for Reworking of Active Pharmaceutical Ingredients and Drug Products, Assigning Expiration Dates, Product Complaints, Annual Product Records Review, GMP Training, Returned goods management, Quality Agreements Validation Practices Analytical Methods Validation, Biological Test Methods Validation, Equipment Cleaning Validation for Active Pharmaceutical Ingredients (APIs), Equipment Cleaning Validation for Drug Products, Laboratory Equipment Qualification, Packaging Validation, Process Validation for Active Pharmaceutical Ingredients, Process Validation for Drug Products and Medical Devices, Facility, Utility and Equipment Systems Validation, Validating Aseptic Processing of Active Pharmaceutical Ingredients (API), Validation of Analytical Methods for Equipment Cleaning, Validation Requirements and Documentation Read More... Copyright © 2011 gmpqualityup.com. All Rights Reserved