Pian uniform charactor and quality within Epecifind limita: om. in tho cash of Atrug product. produced by ‘continuous process, itis a specific. identified mount produced im'f unit of time or ‘quantity’ in a manner that assures 1ts faving ‘uniform character and quality ‘within specified timits. {GD Lot. muonber, control number, or batch number "means any distinctive Combination of letters, numbers, or Symbole, or any comblnation of them, ‘fom which the complete history of the manufacture, processing, packing, 4holding, and distribution of a batch or Jet of drug product or othor materiel tam be determined 1G) Manufacture, processing, packing, on holding of 4 drug product Includes Packaging “and ‘labeling operations, esting, and quality control of drug products (08) Tho torm modicsted food moans any Type B or Types © medicated feed 45 dofloed in $5583 of this chapter. The feed contains one or more drugs se de fed tn section 2it(g) of the act. The manufacture of medicated feeds 16 sub Ject to the requirements of part 225 0f this chapter, ‘di The torm medicated premix mesns a ‘Type A medicated article as defined {in §5503 of this chapter. ‘The article containa one or more drugs aa defined {n'section 2012) of the act. ‘The manu facture of metivated premixes 1s sub Ject to the requirements of part 225 of this chapter, 15) Quality control unit moans any person oF organastional element dos Jmatod by: the firm to bo responelble {er the duties relating to quality con ‘yo 16) Strength means: {Tho concentration of the druz oub- stance (for example, weight welett wroighuvolume, or unit” dosavolume Tals), andor “ii ‘The potenoy, that ie, the thera. peutle activity of the drug proauct as Indicated. by appropelate. laboratory teats oF by adequately developed and ontrolfed clinial data (exproseed, Tor fxample, in terms of units by reference fora standard). “dt) Theovetea! yield moana tho quan- {ty that wonld be produced at any ap propriate phase of manufacture, proe- fesing, oF Backing of m particular dru 21 CFR Ch. | (4-1-06 Eattion) product, based upon tho quantity of Components to be used. in the ebsence fof any loss oF error in actual produce “GB) Actual yield means tho quantity ‘that is actually produced at any appro- plate phase of manufactare, “proce Seeing, oF pickling of parkcala drag product. 18). Percentage of themeticul yieta means the ratio of the actual yield (at fany appropriate phaso of manufacture, Drocossing. oF packing of & particular rug product) to the theoretical yield (at the ame phase), stated as a per centage, (20). Acceptance criteria, means. the product specifications and acceptance! Tojection criteria, such ee aovoptablo Gquality lovel and unacceptable quality vel, with an associated ‘sampling lan, that are necessary for making & Seelsion to accept oF Feject a lot or baton (or any other conventent su soups of mantuactured unt, (21) Representative sample. means a ‘criteria such at random sampling and {ntended to acoure that the sample a= Curately portrays the material belng sampted, (22) Gang-printed labeling moans tac boling derived from a shest of matarial fon which more than one item of label= {ng is printed. (42 PR sT6, Sop, 2,178, a amended a 5 JF Tm, Dae. 19 68H 58 A 9 188) PART 211—CURRENT GOOD MAN- UFACTURING PRACTICE FOR FIN- ISHED PHARMACEUTICALS Subpost A—General Provisions ‘Subpart 8Orgonization and Perzonne! atin Respoabiee of go Subport C—Buildngs and Facitios 2,42 Desi an constracton estar atFood and Drug Administration, HHS cola. LS Seware ah rtm ELE china oi ote ‘Subpart D—Equipment {21161 Byaipment diz, ie, and ooaton ELL6 qupment contraction |Lst guipmont “clear "and matnte Subpart E—Conttol of Components and rug Produc! Containers ond Closuree Toate ars prfast costae a suiting and operon or rjstion ot amit ice ef aprored components, érar {8 Rovesting” of approvod components, tray product containers, and cow, suid ect! componenia "tra roieet 258" Drug protect vntaibers and owes, ‘Subpart FProduction and Process ‘Contois HILO, Bari and testing of 3-pooses ‘atari and drut peat [BLLa, Control of miorviolopten conan Subpart G—Packaging ond Labeling ‘Contel 28 serie onmiion nt en 28 nies ENS Sache ere oe, “Sou tne a SR erage Subpart H—Holing and Disibution 21142 Warenoasin proces. fui sa Subpart Laboratory Controle ‘Stanley ectna ‘Spot esting toquiements ESboratory animal Subpart J-Recorés and Reports aut ‘Baulpmont conning abd woe og Component. crux product contain ‘stra and labeling roca a1sfat "Eats, protacton and contrat Subpatt K—Retumed and Salvaged Drug Products Drag podactsnvugsng AveoMY: 21 U.S. 52, 31, 8,3, tb, mh eG USC 6 93, Sot ‘Subpart A—General Provisions S211 Scope. (e) ‘Tho regulations im thie part con- taln the minimum current good mania: Taoturing. practice for preparation of drug produets for administration to bu mans or anim “(b) The current good manafucturing practice regulations in this chapter as they pertain to drug products; in parts 00 torough 680 of ts chaptor, a thoy Dertain to drugs that aro also biologi Gal products for numan use and In part Eir of this chaptor, as they’ are appli ‘able to druge that are also Duman fells, tiaanes, and cellular and tieste= Dased products (HCTPs) aa that are drugs (subject to review under an appl cation submitted ander section St® of {the act or undor a biological product i= conse application under section 351 of ‘the Public Health Servion Act), pple- ‘ment and do not supersede the regula: ons In thle part untess. the regulac tions expllcitiy provide otherwise. In 135eas ‘ho ovont ofa conflict hotwoon applica ble ‘regulations In this part and in Other parts or chs chapter. oF in Darts {00 through O80 of Uhis chapter, or in part 1271 of this chapter, the Feaelation Specifically appltcable™ to” the crue product in question shall supersede the oro genera 1G) Pending consideration of a pro posed exemption, published in the FED Enal, Ruoisten of Soptombor 20, 1078, the roquirements in this pert shall not be enforced for OTC drur products if the products and all their Ingredients fre Ordinarily marketad end consumed SS human foods, and which products fay aleo fall within the Tegal defla> Hon of drugs ‘by virtue of their in ‘use. Thorefore, until farther no ‘oyulations under part 110 of this chapter. and where applicable, parts 113 foie of this chapter, shall bo applied 4m determining whether these OTC cruz products that are also foods are manus Factared, procoesed, packed. oF ‘eld tinder cament good” manufacturing practice (42 BR un, Spe 29, ae mand at 62 hat De a a $2113 Definitions, ‘The definitions set forth in §2103 of, this enaptor apply In this part. Subport 8—Organization and Pan Breanne $211.22, Responsibilities of quali ‘control wie ai (a) There shall be a quality control anit chat shall have the reeponeibility And authority to approve or reject all Compononts, rug’ product containers, losures, in-process. materlals, pack Aging material” labeling, and "drug Drodueta, and the authority to reviow roduction records to assure that 0 frrore have occurred or, If orrore have Decurred, that they have been fully ine Yestlyated. ‘The quailty contro! unit hall be responsible for approving ot be Jeotng drug products “manufactured, Drocessed, packed, or held under con fact by another company. Gb) Adequate laboratory faciities for the tasting and approval (or rejection) of components, "druz~ product con fainers, closures, packaging materials, 21 CFR Ch. | (4-1-06 Eattion) {in-process materials, and drug products shall be avallable to the quality cane ‘rol unt. {The quality, control unit shat! nave the responsibility Tor approving fr rejecting all procedures or specificay Hone impacting on” the. Identity, strength, quality, and parity of ths ‘amg prod. “d) "The responsibilities and proce. ‘aurea applicable to the quality control ‘Unie shall be in weleing” such weitcen procedures shall be followed 921125. Personnel qualifications. (e) Each porson onzagod in the mana tacture, processing, packing, oF holding (fe drag product shall have education, ‘raining, and exparionco, or any com: ination thereof’ to enable that person, to perform the assigned functions, ‘Training shall be in the particular op- erations that tho employee. performs ‘and. in current. good manufacturing Dractico (neluding’ the’ current 700d ‘munafacturing practice regulations in {his chapter and written procedures re- ‘quired by these regulations) as they re= Inte" to the employee's functions, ‘Troining In current good maniac: turing practice shall be conductod by Gualifed individuals on continuing ‘asia and with sufficlent frequency to gure that employees romain familar ‘with CGMP requirements applicable to them, (} Bach person responsible for super viking ‘the manainctare, processing, Dacking, or nolding of a arug: product Shall have the education, training, and experience, oF any combination thor fof, to perform assigned functions in ‘such a manner as to provide assurance hat the drug product has the safety, ‘entity, strength, quality, and purity {hat It purports or Is represented. to possess (©) There shall be an adequats aum- ber of qualified personnel to perform and Suporviso the manuficture, proce eoing, packing, or Holding of each drag product $211.28 Personnel responsibilities. (a) Personnel engaged in the mana- facture, processing, packing, or holding of a diag” product. shall Wear clean Clothing. appropriate for the duties {hey perform. Protective apparel, such 136Food and Drug Administration, HHS ts hoad, faco, hend, and arm coverings, Shall be worn as necessary to protect ‘rus products trom contamination (@) Personnel shall practice 00d sanitation and health habits “G) OMly personnel authorized by suc pervisory personnel shall enter those froas of tho buildings and facilities Alestznatod as limited-access areas, “d) Any person showa at any time ther by moleal examination or supor- isory observation) to have an appar ft Hines or open tesfons chat may at versely effect the safety or quality of {rug products shall be excluded from Airecr contact with components, drug broduct containers, closures, ln-procass materials, and drug product until the tondition is corrected or determined by competent: medical personnel not to Jcopardize the safety or quay of dru products. All personel ‘chall be. in tracted to report to supervisory por Sonel any health conditions that may Have st adverse effect on drug prod $211.84 Consultants. Consuttanta advising on the manu- factare, processing, packing, or holding of drag’ products shall nave suffioient fducation, training, and experience, or tiny combination theraot, to advise on {he subject for which they are retained Records. shall be. maiutained stating fhe name, address, and. quallfieations of any consultants ‘and the type of fervlee they provide ‘Subpart C—Buildings and Faciliies $211.42 Design and construction fea- ‘res, (a) Any building or buildings used in the manufaetare, processing, packing, or holaing of «drug product shall be of Suitable sia, construction aad location fo. faciieate cleaning, malntonance, tha proper operations, “) Amy steh Dolldini shall nave ade- quate space for the orderly placement or equipment and materials to prevent mmixape between different compononte, rug product contalaors. closures, la- Boling, in-process materials, or drug products, and. to. prevent contamina Hon. ‘The flow of components, drug product containers, closures, labeling Ineprocess materiale, and drug products s2naa through the building or bulldinge shot be designed to prevent contamination “c) Operations. shall. bo. performed ‘within spocifieally defined areas of ade- quate size. There shall be separate oF {lafined areas or such other control sys toms for the firms operations as are necessary to prevent contamination of mizupe during the course of the [ol- owing procedures: (0) Receipt, identification, storage, and’ withholding rom use of compo: nents, drug product containers, clo- sues, end Iaboling, ponding tho appro- priate sampling, Costing, or examina ion by the quality control unit before Telesee for manufacturing oF packs 2) Holding rojected components arug product. containers, closures, a Isbeldng before dlspos! tion (8) Storage of released components, darug product containers, closures, and Inboting: 1c) Storage of in-process materials: (5) Manufacturing and processing: op- erations; (©) Packaging and ta ations: (D) Quarantine storage before release of drug products; (© Storage of drug products after re- Tease: (©) Control and Inboratory oper ations: 110) Aseptic processing, which in- ‘tudes as appropriate: () Floors, walls, and ceilings of smooth, nard Gurfacce that are eaeily ‘leanabie (i) Temperature and humidity con- trols ‘iii) An tr supply Altered through high-efficiency’ partioulate alr Divers under positive pressure, regardless of ‘whether flow is laminar or nomiaminas: (ly) A system for monitoring environ ‘montal conditions: (8) A system for cleaning and dis- ‘nfecting the Toom and eqipment to produce asoptic conditions: (wi A-aystem for malutaining any ‘equipment used to control the aseptle ‘conditions. “) Operations relating to the mana- {ncture, processing, and packing of pen= {olin shall be performed in facies ing oper astsanae separate from those used for other dru Droduets for human use. 198 Gur, Sone, 29.1, as monde at Presi, Jon 3805) $2144 Lighting. Adequate lighting shall be provided small areas, 821146 Ventilation, air filtration, air Tieating and cooling. a) Adequate ventilation shall he pro- idea “@) Equipment for adequate control over air pressure, micro-organisms, Aust, humidity, and tomperacure shall bbe provided when appropriate for tho manufacture, processing. packing. oF holding of drur product. (c) Air filtration systems, including profiters and. particulate mattar alr Fier, shall be used when appropriate fn alr supplies to production areas. Tf Ar Is reclreulated to production areas, ensures shall be taken to control re Ghroulation of dust from production. Ia ‘reas where alt contamination ocours fturing production, thore shall be ade quate exhaust systems or other sys toms. adoquate to control contami ‘) Atr-handling systems for the man- wacture, provessine, and packing of Denielllin shall be completely separate Brom thoae for other drug products for $2148 Plumbing (@) Potable water shall be supplied under continuous poeltive preasure in a lumbing aystem free of dofecte that ould contribute contamination to any Atrug product. Potable water shall meet the standards prescribed in the Bax Fonmontal ‘Protection Agency's | Pr ‘mary Drinking Water Regalations set fort in 40 CPR part Jal. Water not meoting such standards shall uot be permitted in the potable water system. “@) Draine ehail be of adequate size and, whore connectad directly to a Sewor, shall bo provided with an air ‘reals or otter mochanical device to prevent baeke-siphonage. [gh PR Jun, Sone 29.1, as atone at 8 Pre ism Se 6) 21 CFR Ch. | (4-1-06 Eattion) $211.50 Sewage and refuse, Sewage, trash, and other refuse in and from the building and. imediate Dromisoe shatl bo digposed of in s caf Ad sanitary manner 9211.52 Washing and toletfeclties, ‘Adequate washing facilities shall be provided, including not and cold water, Soap oF dotergent. air driers or siarle- Service towels, and clean tollet facil ce caally acooetble to Working areas $211.56 Sanitation, () Any bullding used In the manutac- tare, processing, packing, or helding of drag product shall bo maintained in {lean and sanitary condition, Any sich ‘ullding shall be fee of infestation by rodents, birds, lnseets, and other Vermin’ ther’ than laboratory ani mals), "Trash and organte waste matter sal be held and disposed of in @ times Iv end sanitary manne. (b) Taare shall be written procedures assigning responsibility for sanitation ‘and describing Ia sufficient detall the leaning’ achedules, methods, equip. ‘ment, and. materiale to bo used in leaning. the Dulldings and teliites: fsuch written procedures shall be To Towed! “o) There shall be written procedures {or dee of sultable rodentieldes, insect ides, fungicides, tamigating’ agents, ‘and. cleaning and eanitizing agente, ‘Such written procedures shall be do- signed to prevent the contamination of ‘equipment, componente, drug product containers) closures, packaging. label. ng materiais” or dus. products and sat be followed. Rodenticides,snsesti- Eidos, and fansicidoe shall not bo used ‘unless registored and used Im accord ‘ance with the Federal Insectielde, Pun Sicide, and Rodenticide Act (7 USC. 3). “d) Sanitation procedures shall apply to work performed hy contractors. or tomperary omployooe as woll as Work performed ty futime employees dur= Ing the ordinary course of operations. $211.58 Maintenance. ‘Any bullding uood in the manasac- tue, processing, poking, ar holding of ‘drug product shall be maintained In & ood state of repatr. 138Food and Drug Administration, HHS Subpart D—Equipment $211.68, Eagwloment design, size, and quipment used in the manufacture, processing, packing, of holding of @ frag produce shall bo of appropriate de Sten, ‘adequate size, and suitably” To fated to faciftate oporations for ite in- fended ‘uso and for its cleaning and maintenance, $211.85. Equipment construction, a) Bxuipment shall be constructed so that surfaces that contact components, in-process materials, or drug products hall not be reactive, additive, or abe forptive so as to alter the safety, iden- tty, strength, quality, oF purity of the (rug ‘product’ bayond the oficial or ther éstablishod requirements, “(b) Any substances required for opor- ation, such as Tubricants oF coolants, hall not come into contact with com: ponents, drug product containers, lo Sures, insprocess materials, or dru products ao.as to alter the safety, den Ey, strength, quality, or purity of the ‘rug ‘preduct’ beyond’ the ficial or ther éstablishod requirements. sans sn cleaning and main- Equipment cleaning (a) Bquipment and utensils shall be cleaned, maintained, and sanitized at ‘appropriate intervals to prevent. mat functions or contamination Wnt would altar tho safety, identity, stroneth, fquality, or purley of the drag product Devond the Oficial or other established requirements. “(b) Written procedures shail be estab lished and followed for cleaning and malntenanee of equipment, including {teuae, usod in" the manufacture, Drocessing, packing, or holding of a Atrug product. ‘These provedures. shall Include, but are not nevessariy limited {6 the folowing: “i Assignment of responsibility for cleaning and maintolaing equipment: (@ Maintenance ond cleaning sched tes, including, whore "appropriate, Sanitizing schodules “(3) A description in sufficient detail of tho mothods, aquipment, and mace Flals used in cleaning and maintenance operations, and. che methods of dls Assembling and reassembling “equip 9211.68 mont as nocossary to assure propor ‘leaning and maintenance: Removal of obliteration of pre- ‘logs bateh Identification: '® Protection of clean equipment ‘rom contamination prior to use {Inspection of equipment for clean- ness immediately before use {o) Records shalt be Kept of mainte- nance, cleaning, sanltiging, and Inspec- ‘om aa specified in §§211 6b and 211 102, $211,689 Automatic, mechanical, and ‘leetronte eauipment. (a) Automatic, mechanical, or elec. twonte. equlpment” or other types “of ‘equipment, Including computers, or Yer lated syatems that will perform a fune- tion eatistavtortig, may be used in the manufacture, processing, packing, and Holding’ of a" drag product, If such ‘equipment i 20 used. It shail be To: Unely calbrated, Inspected, or checked faccording to a written program de- Signed to aeaure proper performance, Woteen ‘records of ‘those calitration checks and Inspections shall be male tained, “b) Appropeiate controls shall be ex- ervised over computer of related €9s- tems to cssure that chonges in master production and control records or othor Tocords aro instituted only by suthor- {ed personnel. Input ‘to and ‘eutpat from the compiiter or related system of formulas or other records or data shall be checked for accuracy.."The deare= and. frequency of inpuvoutpat ‘Terification shall be based on the com: Dlexity and reliability of the computor for related system. A backup file of data ntared into the compater or related faystem shall’ bo maintained ‘except ‘Where certain data, such aa. caleulae Uons performed in connection with Tab- oratory analysis, ere eliminated by Computerization ‘or other automated processes. In such instances 4 written Tecord of the program shall be maine {tained along with appropriate valida” ‘on data. Hard copy or alternative sy ‘tems, sich as. duplicates, tapes, oF imlerofilm, designed to. assure that Dackup data are exact and completo ‘and that it is secure from alteraeion, Inadvertent erasures, oF Toss shall be rmuineained (48 BR SST, Sop, 2,17, a arene at 60 $F ta, Jon- 0166) 139g2u.7a $21.72 Fitters. Filters for ligula filtration used in the manufacture, processing, oF pack= Ing “ot injectable’ drag producte in {ended for human se ahall not release fHbers into sun products. Piber-releas= ing Milters may mot be uscd in the men {actare,. processing, vor packing of {hese injectable drug proaucts unless 1 {snot possible to manufacture such dug products without the use of such filters If ase of 4 fbersreleasing filter Js necessary, an additional non-ffber~ releasing Miter" of 02 micron “max mum moan porosity (0.45 meron ifthe manufacturing conditions so dictate) Shall subsoquentiy’ be used to. reduce fhe content of” particles im the Injectable drag product. Use of an as- Destoscontaining ter, with or wich fut subsequent use of a specific non Mborreleasing itor, te" permissible nly upon submission of proot to the Spproprlate bureau of Lie Food and Drag Administration that use of 8 non fMber releasing ‘filter will, or ia Tkely fo, compromise the safety or effective sews of the Injectable dru product. E_Control of Compo- ‘nents and Drug Product Con- fainers and Closures $211.80 General requirements, a) There shall be written procedures dtesoribing tn sulfielont detail the re feipt, identification, storage, handling, fampiing, testing, and approval or re Jeckion ef components and drus prod {et containers and slosuroe; euch Wwrit- ten procedures shall be followed (o) Components and drug” product containers and clogures shall” at all Himes be handled and stored in aman ner to prevent contamination. {) Baswed or Doxed components of drug. preduct ‘containers, or closures Shall be stored off the floor and ait bly spaced to permit cleaning and In “@) Bach container or grouping of containers for components. oF aris Droduct containers oF closures shail be Ientified with a distinctive code for feel Tot in oach shipmont- recolvod. ‘This code shall be used tn recording the Alsposition of each Tot. Hach Tot shall be appropriately. Identified ae to ite 21 CFR Ch. | (4-1-06 Eattion) tates (Le, quarantined, approved, or rejected). $211.42, Receipt and storage of unter ‘cd components, drug product or fainors and closures {w) Upon revelpe an before aveent- ance, each ‘ontainer or grouping of Containers of components, drug prod ‘net containers, and clorires shall be examined visuaily for appropriate la- Deling’ as to contents, container das fago or broken seals, ond. contamnina ‘(b) Components, drug product. con- tainers, and closines thal be. stored tunder quarantine unt! they have been {ested or examined, as appropriate, and released. Storage within the area shall Conform to the requirements of $21.00, 5211.84. Tosting and approval or rejec- tom af componentay drug Product ners; and closures. (2) Bach lot of components, drag product containers, and closures shall be seitnnerd trom use anti the Tot has been stmpled, tested, of examined, as appropriate, and released for use by the ‘quality control unit “@) Representative samples of each slpment of euch Tot shat! be collected {or testing or examination. ‘The mum Yor of containers to be sampled, and the amount of material to be taken fom each container, shall be Tased ‘upon appropriate criteria such as sta- Utica! criteria. for componont varla~ bility. confidence levels, and degree of precision desired, the past quality i {ory of tho supplier, and tho quantity needed for analysis and reserve Where required by $211.70, “) Samples shall be eotlected In ac- cordance "with the following proce: ‘ores ‘0 Tho containors of components se- lected shall be cleaned where i ‘esary, by appropriate means (@ ‘ihe contaluers shall be opened, sampled, and resealed In a manner do: Slened” to prevent, contamination of their contents and comamination of other companents, drug product con: {tainer, or eloet 18) Sterile equipment and_asoptic sampling techalques shall be Used when eceaeaty. uoFood and Drug Administration, HHS (4) 18 itis necessary to sample a.com- ponent from the top, mice, and bot- fom of {ts contsiner” such saimple sub Aivisions shall aot be composited for testing ‘) Sample containers shall be identi- fied so that the following information ‘can be determined name of the mate: Hal stmpled, the lot number, the con: fainor trom which the. sample was taken, the date on which the sample ‘was talcen, and the name of the penson ‘who collected the sample, (6) Contalners out which sampies rave been taicen sail he marked to show that eamploe havo boon romoved ‘rom tem, (@) Sainples shall be examinod and ted a follows! ‘Gy At least one taat shall be con- ‘aucted to verity the Identity of each component of a drug product. Specific dontity teste, if they exist, chail bo nse, ‘G) Bach component shall be tested for conformity with all” appropriate ‘written specifications for purity. strength, and quality. tn Ile or such testing by the manufactures, a report of analysis may be accepted from the Supplier of « component, provided that ft Toast one ‘conducted on ‘manufacturer, Tanufacturer’ eataflishes” che rell= ability of the” supplier's analyses through appropriate validation of the supplier's tect roculto at appropriate intervals ) Containers and closures shall be tested for conformance with all appr0- priate writen procedures. In Hew of ‘Such testing by" the manufacturer, certificate of testing may be accepted ‘om the. supplier, provided that at Jeart a 'vinual identification is con uctod on such contalnerstelosures by fhe ‘manufacturer and provided that the manufacturer establishes the Yell- abiity of the supplier's test. results throukh ‘appropriate validation of the supplier's test resulto at appropriate intervala (G) "When appropriate, components all be microscopically examined ‘@) Bach lot of @ component, drug product container, or closure that Hable to coutamination with tlth, in sect infestation, or other extraneous S219 fadulterant shall bo examinod against fstablished spscifeatigns far auch can tamination, (6) Hach lot of @ component, arur product container, or closure that is Iablo to. mleroblologtoal contamina tion that is objectionable in viow of its nvended ose shall be. subjected. t0 ‘lcroblological tests bafore use. (e) Any lot of components, drug prod- uct containers, oF closures that meets tho appropriate written spocifications of identity, stronzth, quality, and poe rity and related tests under paragraph (Gof this section may be approved and eleased for use. Any Tot of such mate- Hal that does not meet auch specifica tions shall bo rejcted. (4s Pm SST, Sot, 2,17, amend a 83 ‘a i, or 3,00) 21120 Use of spproved componen 7 drug product containers, and clo- Components, are product com tainern, and closures approved for ane Shall bo rotated so that tho oldest ap. Drove. stock is used frst. Deviation ‘rom thia reqairement fe permitted if toch deviation ie temporary and appro” piace $1187 Retesting of approved compo- ents drug product containers, aod Components, drug product con- tainers, and olosires shail be retested for reexamined, as appropriate, for iden~ tity, strength, quality, and parity and approved or rejected ‘by the quallty contro! anit in accordance with $211.81 fas necessary, eg, after scorage Tor Tons periods or after exposure to alt, heat or other conditions thst might ad versely affoct tho component, drag ‘product container, or closure S21180 Rejected components, drug ‘product containers, and closures Rojected components, drug. product containers, and closures thal! bo idon= {ied ‘and controtiet under a quar- antine “system designed "prevent their use in manufacturing” oF proc ‘asing operations for which thoy are ‘unsuitable, ua