TRAINING REPORT BOROCAPS.docx

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TRAINING REPORT BOROCAPS hhhh

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COMPANY HISTORY

The unit of Borocaps pharmaceuticals is located in H1-46, Riico Industrial area , sarna dungar Jaipur, the company is growing pharmaceutical manufacturer in India. This unit of Borocaps pharmaceuticals is a dedicated manufacturing facility for β Lactum Antibiotic formulations. The unit covers total 7780 Sq.ft. constructed area. There are three different interconnected blocks viz. Administration, Production & Ware house. The manufacturing facility has infrastructure for the production of Capsule, Dry syrups, Oral liquids. There is an in process control laboratory located In the production block. The change room for entrance of personnel of production, quality assurance for β Lactum & Non β Lactum are housed in one block with shoe racks & lockers to keep Valuable goods.

1. Name and exact address of the site : Name of company, postal address including code:Borocaps pharmaceuticals H1-46, Riico Industrial area, Sarna dungar Jaipur.302012 Rajasthan, India.

Telephone No. of contact person: Contact person Telephone Nos. : Manoj Bhargava (Proprietor). : 9214334076 (Factory) 9413134078 (Mob) 0141-2282360 (Res.)
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A. Pharmaceuticals Mfg. Activities as permitted by the licensing Authority: BOROCAPS PHARMACEUTICALS is licensed to manufacture, store & distribute For sale of different formulations of capsules, Dry syrups, Oral liquids (under schedule C& C (1) and other than C& C (1) of the Indian Drugs & Cosmetics Acts & Rules, 1945) By the Drugs Controller and Licensing Authority, Rajasthan (India).

B. Any other manufacturing activities carried out the site : Apart from the activities mentioned in section A no other manufacturing activity is Carried out at the site. C. Type of product licensed for manufacture in Borocaps Pharmaceuticals Jaipur. The firm will manufacture liquid, capsules, β Lactum & Non β Lactum with Dry syrups.

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RECEIVING / DISPATCH OF MATERIAL

↓ ---------------------------------------------------------------------------------------↓ Raw Material ↓ Quarantine ↓ Sampling ↓ Q.C.Analyais ↓ R.M.Store ↓ PKG. material primary ↓ Q.C.checking ↓ PKG.material secondary ↓



Dispensing ----- Formulation / Processing -------- ↓  Primary Packing  ↓  Ancillary area  ↓  Q.C.testing  ↓ o Finished goods store
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DESCRIPTION OF THE FIRM :

A. Nature of construction and fixtures / fitting. Material used in construction is cement, bajri & bricks, where as outer walls Are build of stones. The windows & door are made up of aluminum & provided glass panels. The floor is made up of Kota stone. The complete building is painted By matt finish washable paint. The corners of roof, walls & floor are coved

B. Brief description of ventilation systems. The windows are provided fixed glass panels fitted with aluminum frame to stop the direct air. The firm has also provided air handling system in liquid section With prefilter 20 micron & 5 micron primary filter. The firm has no aseptic area For hazardous & toxic material, we have an almirah.

C. Description of planned preventive maintenance programmes for premises & of The recording system:

Rodent Control: Rodent control must be done at least once in year & record maintained. Procedure: As per S.O.P. Pest control: Insect control: As per S.O.P. Insectoquitor is provided in production area.

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D. Number of employee engaged in production, quality control, storage and Distribution:

The firm has one production manager, one, Q.C. in charge, Q.A.manager & one Marketing manager. There are eleven workers including Skilled.

Number of employees in production Number of employees in quality control Number of employees in storage and distribution

9. 1. 1.

E. Use of out side assistance in analysis: The firm has its own testing laboratory, but for some sample will be Send to M/. Oasis Test House Ltd., S-P-2, 22 Godam industrial Area Jaipur, M/s. Sri Ram Test House Delhi. & Analyst Labs Pvt. Ltd. Jaipur.

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Quality management system:

1. Quality :We will prepare the end product as per official books and as per in house Specification. The firm will also fulfill packing requirements for safety & product Acceptance, keeping, trade requirement to make it profitable for all. 2. Quality policy :Regarding quality policy we have appointed Q.A.manager who will assign the responsible person. 3. Quality Management :Regarding quality management we have Q.A. manager who will be Responsible for quality management. Q.A.manager has appointed Q.C.in charge who will be responsible for testing and in process control. Q.A.manager has appointed Mfg. Chemist who will be responsible for manufacturing quality. All the S.O.P. will be prepared by Q.A.manager who will assign each work to responsible person. The quality management system can be renewed after suggestion of any worker or staff. a. Each & every steps of manufacturing is documented and signed by authorized person. b. Specification of material is documented. c. Method of manufacture and control is documented. d. Every product has master formula record. e .S.O.P. has been prepared to ensure the quality management system.

Sanitation in the mfg. Premises & equipments :
Premises should be cleaned every day. The floor should be cleaned by phenols everyday. The Premises should strayed with insecticides and pest control by using pesticides the Record of pest control will maintained. The over head tank will be cleaned at 15 days Interval & will keep the record. 6 S.O.P. for cleaning mfg. premises will be maintained if includes. ▶ Removal of dust. ▶ Minimize cross contaminination.

▶ Reduction of microbial load. ▶ Control of insects & pest by providing barrier & filter air 1. S.O.P. for cleaning equipments, it includes i.e. step of cleaning: ▶ Equipment disassembling. ▶ Prewash ▶ Initial wash ▶ Final rinse ▶ reassembling the equipment

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List of machinery:We have three sections i.e. liquid / oral, general capsules & β Lactum capsules Section wise list of machinery are as follows Liquid/ oral section: 1. Bottle washing machine 2. Bottle Drier

3. Stirrer 4. Emulsifier 5. Filter press 6. Volumetric filling machine 7. Cap sealing machine 8. Empty bottle checking board 9. Filled bottle checking board 10. D.M.Water plant 11. S.S.Tanks Capsule section β Lactum 1. 2. 3. 4. 5. 6. Mixer Conical. Capsule filling Machine with change parts. Dehumidifier A.C. Thermometer Capsule Counter

General Capsule section 1. 2. 3. 4. 5. 6. 7. 8. 9. Mixer Conical. Capsule filling machine with change parts. Dehumidifier A.C. Thermometer Capsule Counter Stripping machine with change parts. Sachet filling machine Blister packing machine
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OUALITY ASSURANCE:
A. Organizational chart showing the arrangement for quality assurance including Production & quality control.

QUALITY ASSURANCE MANAGER

↓ Production manager

↓ Q.C.Incharge

↓ Commercial& Administration

1. Production manager is having 22 years experience of Mfg. of medicines & will be Responsible for all Mfg. Activities. 2. Quality control manager is B.S.C. (20 years experience) & Approved in testing, is responsible for the all analytical activities in the laboratory. B. Qualification experience & responsibilities of key personal. S no. 1. 2. For Manufacturing Mr. Manoj Bhargava Mrs. Anushua Bhargava Post Production manager Q.A. Manager Qualification B.Sc. M.A. Bed. Experience 22 Years 20 Years

For Testing:S.no. 1. For Testing Sushil Kumar Sharma Post Q.C.Incharge Qualification B.SC. Experience 20 Years
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Health requirements for personal engaged in production : The firm has appointed M.B.B.S. Doctor who has checked all the employees at the time of Employment and also will check annually of each employee. The Doctor checks the Fitness and free from infection & Contagious diseases. Q.A. manager has assigned to prod. Manager for educating the workers for health & Hygiene i.e. to keep the nail short, hair short, wash & clean hand, wear head gear & Nose mask, Apron. Personnel Hygiene requirements including clothing :

-Written instruction is displaced to ensure personal hygiene in change room & Other strategic locations. No person showing illness is allowed in manufacturing area. All person wears clean body covering & head gear with nose mask All personal wear slippers provided by factory in manufacturing area & separate slippers for toilet.

Premises : Factory is constructed in double story, ground floor is for oral liquid & capsules are on First floor. Both the raw material stores for β Lactum & non β Lactum are separate and Their entries are also separate.

Packing

Finished Goods

Production Area Raw material ↓ Office

Workers entry

Office staff Entry

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Simple plan:
1. Raw material store general 2. Raw material store β Lactum. 3. General Caps. Section. 4. Ancillary Area for General Capsules. 350 280 280 113 Sq.ft. Sq.ft. Sq.ft. Sq.ft.

5. β Lactum Cap. Section. 6. Ancillary Area for β Lactum capsule section. 7. Change room non β Lactum 8. Change room β Lactum 9. Office room. 10. Lab. Instrument room. 11. Lab Chemical room. 12. Finished goods store 13. Return goods store 14. Washing, Drying Bottle room. 15. Ancillary Area for liquid / oral. 16. Mfg. Filling Sealing of liquid / oral. 17. Pkg. Room for liquid/oral. 18. Stripping room for liquid/oral. 19. Primary pkg. material store. 20. Secondary pkg. material store.

340 102 117 117 124 126 126 400 60 165 144 495 250 196 280 190

Sq.ft. Sq.ft. Sq.ft. Sq.ft. Sq.ft. Sq.ft. Sq.ft. Sq.ft. Sq.ft. Sq.ft. Sq.ft. Sq.ft. Sq.ft. Sq.ft. Sq.ft. Sq.ft.

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Documentation :
▶ Every document should prepare by the quality control assurance officer with The help of production manager and analytical in charge and should revise time To time. ▶ Necessary documents including master formula record should prepare by Production Manager.

▶ Mfg. Area should be tested at the intervals for microbial contamination. ▶ Swap test required for the change parts of capsule blister packing machine.

Documents includes the following :

I. II. III.

Arrangements for preparation. Necessary documents for the manufacture. Microbiological control about Air & Water.

▶ S.O.P. for cleaning factory premises. ▶ S.O.P. for cleaning outside factory. ▶ S.O.P. for entry of R.M. in deducting area to quarantine area of R.M. Section. ▶ S.O.P. for sampling of raw materials. ▶ S.O.P. for cleaning equipments. ▶ S.O.P. for cleaning machinery. ▶ Master formula record of every product. ▶ Raw material register. ▶ Pkg. Material Register. ▶ Flow sheet for production. ▶ Line clearance Record. ▶ Distribution Record. ▶ Return goods Record. ▶ Rejected goods record . ▶ S.O.P. for cleaning of storage tank.
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▶ Validation of equipments. ▶ Ref. samples record. ▶ Documentation of self inspection. ▶ Documentation of quality assurance. ▶ Documentation of quality assurance. ▶ Documentation of in process control.

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Production :

A. Brief description of production operating using wherever possible flow sheet & chart showing imp. Parameter. The he flow sheet will be as follows: Separate entry gate for raw material and Pkg. Material. We have separate Dedusting area adjust to gate. After removal of dust gunny bags R.M. kept in Quarantine area. Separate area for sampling in Raw material room. After passing of raw material from Q.C. will kept in tested area. The Raw material room, Is A/C. To maintain the temperature. The Raw material is dispense to the production department from the dispensing area which is also A/C. Raw Material & Pkg. Material. ↓ Dedusting Area ↓ Quarantine Area ↓

-

Sampling Area ↓ Quarantine Area ↓ Tested passed Area ↓ Dispensing Area ↓ Production Area

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Other essentials:

Arrangements for the handling of rejected material & product : Separate partitions for rejected, quarantine & tested materials.

Brief description of general policy for process validation : Master formula record for each product. Process will validate by quality Control in charge & production in charge in writing with initials.

Quality Control: Description of the quality control system & of the activities of the quality control Deptt. Procedure for the release of finished products:

Quality Control In charge ↓ Lab. Assistant

↓ Finished goods testing

After receive the pass report of finish product will be released for market. Loan license manufacturer: There is no loan license.

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Distribution, complaints & product recall: 1. Separate register for recording of Distribution of products with all details. 2. Arrangement for the handing of complaints & products recalls. Separate register for complaints & recalls, if gets any complaints of product in market first of all should recall the entire batch from market & should be checked.

Self inspection: Self inspection system is developed for each product & will be followed Strictly. Vendor Development: All starting materials are procured form approved vendors. In case of a new supplier, Audit of site is under taken by the quality assurance manger & material manager & Both technical & commercial strength of the supplier are judged using standard Checklist .A part from this there is a system for routine audits assessment of the Existing suppliers on continuous basic. Similar Practice is followed for suppliers Of printed packing materials.

Release of finished Product for sale:

After completion of the manufacturing activity the batch manufacturing documents are audited by the production executive with respect to completeness & correctness of the data & information’s. The batch documents (BMR & BPR) is reviewed by manager Before submitting the Documents to quality Assurance Department. Finally the Documents is audited by Q.A. Manager for compliance. Having found the document. Correct and complete the batch is recommended for release for sale through a written release note to in charge ware house.
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1. PRESERVATIVES FOR ORAL LIQUIDS :Sodium Benzoate Propyl Paraben Sodium Methyl Paraben Sodium Boronopol Sorbic Acid

2. ADDITINES, EXCEPIENTS FOR CAPSULES :Lactose Starch Talcum

-

3. OVERAGES FOR VITAMINS :25 To 35 % Casper Master Formula 4. OVERAGES FOR ANTI BIOTICS :-

10 % (+ Water % if any as per I.P. , B.P. or U.S.P. )

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COMPOSITIONS OF SOME PRODUCTS:

NAME OF PRODUCT : AMBOPAX
EACH 10 ml. CONTAINS: Terbutaline Sulphate Ambroxol Hydrochloride Guaiphenesin Menthol I.P. I.P. I.P. I.P. 2.5 mg 30mg 100 mg. 2 mg.

Color : Brilliant Blue & Tartrazine Supra

NAME OF PRODUCT : CALCI-DZ
EACH 5 ml. CONTAINS : Calcium Carbonate (Equivalent to Elemental Calcium) Magnesium Hydroxide I.P. IP 150 mg. 25mg

(equivalent to Elemental Magnesium) Zinc Gluconate (Equivalent to Elemental Zinc) Vitamin D3 Flavored Syrup Base Color: Ponceau 4R

USP I.P. q.s.

1.5 mg. 200 I.U

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NAME OF PRODUCT: CYPROHEP
EACH 5 ml. CONTAINS: Cyproheptadine Hydrochloride Flavoured Syrup Base Color: Tartazine

I.P.

2 mg. q.s.

NAME OF PRODUCT:
EACH 5 ml. CONTAINS: Cetirizine Dihydrochloride

SALWIN PLUS

I.P.

5 mg.

Phenylpropanolamine Hydrochloride Paracetamol Flavoured Syrup Base Color: Sunset Yellow FCF

BP. IP

12.5 mg 125 mg. q.s.

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NAME OF PRODUCT: TIKORYL
EACH 5 ml. CONTAINS : Chlorpheniramine Maleate Ammonium Chloride Sodium Citrate Flavoured Syrupy Base Color: Sunset Yellow Fcf

I.P. I.P. I.P.

2.5 mg. 125mg. 55mg. q.s.

NAME OF PRODUCT: VERCID
EACH 10 ml. CONTAINS: Activated

Methylpolysiloxane Magnesium Hydroxide Dried Aluminum Hydroxide Gel Flavored Syrup Base Color: Sunset Yellow FCF

I.P. I.P. I.P.

25 mg. 185 mg. 425 mg. q.s.

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