Overall Overall intention intention and and direction direction of an an organizati organization on regarding regarding quality quality as as formally formally express expressed ed and authoriz authorized ed by the top management
Quality management - encompasses the organizational structure, procedure, processes and resources. - aspect of management function that determines and implements the quality policy. - overall policy of the organization towards quality. Quality assurance Ensu Ensure res s tha thatt pol polic icy y is is bei being ng achi achiev eved ed Overall Overall organizat organizational ional body body which which aims to genera generate te sustaine sustained d confidenc confidence e that the the systems systems of of quality quality control, control, good manufacturing processes and environmental control are in place while embracing the principles of total quality management !Q"#.
$"% $ood manufacturing practice# -
%art art of of qua quali lity ty assu assura ranc nce e &eals with the ris's ris's that cannot cannot be tested, tested, builds builds quality quality into into the produc product. t.
Quality control -
%art of $"% (ocused (ocused on testing testing of the enviro environment nmental al and faciliti facilities, es, materi materials als compon component ent and and product. product. !estin sting g of of prod produc uctt qu qual alit ity y con contr trol ol##
!hree steps of quality control) *. . .
+nspection nalysis ction
Quality control -
/onforms /onforms to standa standards rds and and specific specification ations s through through a system system of of inspecti inspection, on, analysi analysis s of action. action.
0enefits from Q"1) *. . . 2. 4. 5. 6.
"inimize "inimize and and elimina eliminate te the the ris' ris' of mar'eting mar'eting unsafe unsafe products products.. $uarantees $uarantees conforman conformance ce to regulatory regulatory requiremen requirements. ts. $uaran $uarantee tees s produc productt effica efficacy cy.. 3edu 3educe ces s ope opera rati ting ng cost costs. s. 3edu 3educe ces s ope opera rati ting ng loss losses es.. %roduc %roduces es higher higher employ employee ee morale morale "otivates "otivates the the pharmaceut pharmaceutical7 ical7medic medical al professio profession n to sell or prescribe prescribe the the product. product.
0asic organizational chart in a pharmaceutical manufacturing firm
M F ia n a g n e c e c m e e n t Quality management and organizational chart)
n e o
MATERIAL INSPECTION SECTION +nspectors - alert - with experience - well versed with the physical characteristics of materials - 'now the sampling techniques
ctivities) 1ample and examine all raw materials received o 1ample and conduct physical tests on pac'aging materials and manufacturing, filling and pac'aging o operations "aintain periodic examinations on the quality of inventories o %erform audit o 1tations o
8arehouse, manufacturing and pac'aging areas
ANALYTICAL LABORATORY o o o o o o o
rea is separated from production room and biological laboratory 1eparate room shall be provided for instrument 1afety shower and eye-bath shall be in close proximity to the laboratory wor'ing area 1O% and regular calibration for each instrument and equipment. 3eagents 3eference standards 9ey activities) physical and chemical analyses
BIOLOGICAL TESTING LAB ctivities) o o o o o o o
%harmacological, toxicological and microbiological analyses 1eparate animal house and veterinarian :oise should be precluded from areas where animals are used ir handling facilities should be in different from the process air handling facilities /ulture media 1terile conditions Environmental monitoring microbial and particulate matter#
"+/3O0+O;O$+/; !E1!1 *.
ntimicrobial effectiveness testing < to determine the efficacy of antimicrobial preservation added in the formulation.
!est organisms) -
C. albicans A. niger P. aeruginosa E. coli S. aureus
"edia) 1oybean < casein digest 0roth agar 1abouraud &extrose agar7broth for fungi
"icrobial ;imit test < estimation of the following of viable aerobic microorganisms
!est organisms) S. aureus E. coli
P. aeruginosa 1almonella
"edia) +n p= 6. phosphate buffer (luid soybean-casein &igest medium (luid lactose medium .
1terility tests < determine whether a pharmacopeial article purporting to be sterile complies with the requirements.
"embrane filtration uses filter with a nominal pure size of nmt >.24 u /ellulose nitrate filter for aqueous, oily, wea'ly alcoholic solution /ellulose acetate filter for strongly alcoholic solution
&irect inoculation 7 &irect transfer method
"edia) (luid thioglycolate for anaerobic 1oybean-casein digest for fungi an aerobic
(or penicillins and cephalosporins) ? < lactamase is used to inactivate the antibiotic
ntibiotics < "icrobial assay &etermine the potency of antibiotics
!wo methods) *. . . -
/ylinder plate or tube !urbidimetric or tube
0acterial Endotoxin tests &etects and quantifies bacterial endotoxins in the sample @ses ;imulus mebocyte ;ysate ;;# moebocytes from horseshoe crab, limulus polyphemus 3eacts with bacterial endotoxins of gram -# bacteria !wo types) $el-clot technique o %hotometric technique o -!urbidimetric -/hromogenic
0iological 3eactivity !ests, +n vitro &etermines the biological reactivity of mammalian cell cultures following contact with elastomeric plastics and other polymeric materials with direct or indirect contact or of specific extracts prepared from the materials being tested. !hree types) gar diffusion test o &esigned for elastomeric closures in variety of shapes
gar layer acts as a cushion to protect the cells from mechanical damage while allowing the diffusion of leachable chemicals from the polymeric substance.
;eeching < container to the product 1orption < product to the container
&irect contact &esigned for materials in a variety of shapes llows for simultaneous extraction and testing of leachable chemicals from specimen with serum supplemental medium :ot appropriate for very low or high density materials that could cause mechanical change to the cells.
Elution test o &esigned for the evaluation of polymeric material extracts llows extraction of specimens at physiological or non-physiological temps for varying time intervals ppropriate for high density materials and for dose response evaluations
0iological reactivity tests, in vivo &esigned to determine the biological response of animals to elastomeric, plastics and other polymeric materials with indirect or direct patient contract or by the inAection of specific extracts prepared from the sample !hree types)
1ystemic inAection tests o &esigned to evaluate systemic response to the extracts or materials under test following inAection into mice
+ntracutaneous test o &esigned to evaluate local response to the extracts of materials under test following intracutaneous inAection into rabbits
+mplantation test &esigned for the evaluation of plastic materials and other polymeric materials in direct contact with living tissue o
%yrogen test &esigned to limit to an acceptable level the ris' of febrile reaction in the patient upon administration by inspection of the product concerned. &esigned for products that can be tolerated by the test rabbit in a dose not to exceed *> m; per 'g +B in a period of nmt *> mins. 3esult) (irst test) rabbits :o rabbit with rise of >.4 C/ or more no pyrogen# ny rabbit with rise of >.4 C/ or more use 4 more rabbits# 1econd test) D rabbits :mt out of D rabbits with rise of >.4 or more and if the sum of the D maximum temp increase does not exceed . C/ no pyrogen#
SPECIFICATION AND ANALYTICAL DEVELOPMENT %ersonal should also be familiar with manufacturing, research, prout development and statistics /oordinate with other departments for product improvements Establish specifications for raw and pac'aging materials Balidate existing and tentative procedures of testing Establish specification based on validated procedures develop new assay methods for in house &evelop and improve specifications for quality characteristics of the final products
QALITY COORDINATING OFFICE ccessible to manufacturing and pac'aging operation "ain function) documentation "aintain and store batch records (urnish data tract will aid in analyzing product performance +nvestigate product complaints, evaluate returned products and reprocessing procedure +dentify the development group needed in the product improvement %rovide data that give scientific and legal status - "aintain and develop 1O%s