This document provides an overview of 21 CFR Parts 210 and 211, which establish current Good Manufacturing Practices (cGMP) for manufacturing, processing, packing, or holding of drugs. It discusses the scope and applicability of the regulations, key definitions, and the general requirements for facilities, equipment, components, production and process controls, packaging and labeling, and quality control. The goal of the regulations is to ensure uniform quality standards are met without specifying exactly how to achieve them.

1. 21 CFR, Part 210 and 211
current Good Manufacturing
Practice
An Overview of the FDA Regulations
1

2. • CFR – Code of Federal Regulations
(administrative law)
– 50 titles
• Title21– FoodandDrugs
– 1– 1499 Parts
»210 c GMP in Manufacturing, Processing,
Packaging or holding drugs –General
»211 c GMP of Finished Pharmaceuticals
INTRODUCTION
21 CFR, Part 210 and 211

3. 1. Status of the regulations
– Regulationssetforthare“minimum”requirements!!!!
– Coversmanufacturing,facilitiesandcontrolsfor
• Manufacturing,processing,packagingorholdingof a
drug product
– Failuretocomplywillrenderthedrugtobe adulterated
• Thepersonwhoisresponsibleforthefailuretocomply
shallbesubjecttoregulatoryaction
21 CFR, Part 210 and 211
PART 210 GENERAL

4. 210.2 Applicability
– Appliestodrugproductsforhuman use
PART 210 GENERAL
21 CFR, Part 210 and 211

5. PART 210 GENERAL
21 CFR, Part 210 and 211
3. Definitions
• Batch
– Aspecificquantityof drug/materialintendedtohave
uniformcharacterandqualityproducedunderasingle
manufacturingorderformduringthesamecycleof
manufacture.
• Component
– AnyingredientintendedforuseINCLUDINGthose
thatmaynotappearinsuchdrugproduct

6. • Drug Product
– Finisheddosage form
• Fiber
– Anyparticulatewithalengthatleast3timestoits
width
• Active ingredient
– Anycomponentintendedtofurnishpharmacological
activity
21 CFR, Part 210 and 211
PART 210 GENERAL

7. • DrugisdefinedbytheActasanycompoundthathas
effectinthediagnosis,cure,mitigation,treatmentor
preventionof diseaseortoaffectthestructureor
functionof thebodyof manoranimals
• In-process material
– Anymaterialfabricated,compounded,blendedor
derivedforuseinthedrug product.
21 CFR, Part 210 and 211
PART 210 GENERAL

8. • Manufacture,processing,packingorholding includes
– Packagingandlabeling,testingandqualitycontrolof
drug products
• QualityControl
– Anypersonorunitdesignatedbythefirmtobe
responsiblefordutiesrelatingto QC
• RepresentativeSample
– Samplesdrawnonrationalcriteriaintendedto
accuratelyportraythematerial beingsampled
21 CFR, Part 210 and 211
PART 210 GENERAL

9. • Thereare11 subchapters
– IdentifiedbylettersfromAthroughK
• Coversallsectionsof operations
• Designedtobeallencompassing(general)– DON’T
expecttoomanyspecifics
• Thegoalistotell you
WHAT TO DO, NOT HOW TO DO it!
21 CFR, Part 210 and 211
PART 211

10. SUB-PART 'A' – GENERAL
PROVISIONS
21 CFR, Part 210 and 211
211.1- Scope
211.3- Definitions

11. 211.1Scope
– Minimumrequirements
– Appliestodrugsforhuman use
211.3Definitions
– Thosesetforthin210.3areapplicable
21 CFR, Part 210 and 211
SUB-PART 'A' – GENERAL
PROVISIONS

12. SUBPART B – ORGANISATION &
PERSONNEL
21 CFR, Part 210 and 211
 211.22- Responsibilitiesof qualitycontrolunit
 211.25- Personnelqualifications
 211.28- Personnelresponsibilities
 211.34- Consultants.

13. SUB-PART B – ORGANISATION &
PERSONNEL
21 CFR, Part 210 and 211
211.22- Responsibilitiesof qualitycontrolunit
• TheQC unitshallhaveadequatelaboratory facilities
• Theyshallhavetheresponsibility for
approving/rejecting allproceduresorspecifications
impactingthequalityof thedrug product
• Responsibilitiesshallbeinwritingandshallbe followed.

14. 21 CFR, Part 210 and 211
211.25- Personnelqualifications
• Everyoneshallhavetheeducation,trainingand
experiencetodotheir jobs.
• Everyonewhosupervisesthosepeopleshallhavethe
education,trainingandexperiencetoassignfunctionsto
provideassurancefordrugquality.
• Thereshallbeanadequatenumberof qualified
personnel.
SUB-PART B – ORGANISATION &
PERSONNEL
SUB-PART B – ORGANISATION &
PERSONNEL

15. SUB-PART B – ORGANISATION &
PERSONNEL
21 CFR, Part 210 and 211
211.28- Personnelresponsibilities
 Wearcleanclothingandprotectiveapparel
 Practicegoodsanitationandhealthhabits
 Limitedaccessareas
 If youaresick– doyoubelonginthearea?

16. SUBPART B – ORGANISATION &
21 CFR, Part 210 and 211
PERSONNEL
211.34- Consultants.
Shall have sufficient education, training
and experiencetoadviseonthesubjectmatter.
 Records maintained stating the name, address
and qualificationsofconsultants.

17. SUB-PART 'C' – BUILDINGS AND
FACILITIES
21 CFR, Part 210 and 211
 211.42- Designandconstruction features
 211.44- Lighting
 211.46- Ventilation,airfiltration,airheatingand cooling
 211.48- Plumbing
 211.50- Sewageand refuse
 211.52- Washingandtoilet facilities
 211.56- Sanitation
 211.58- Maintenance

18. SUB-PART ‘C' – BUILDINGS AND
FACULTIES
21 CFR, Part 210 and 211
211.42 - Design and construction features
 Anybuildingshallbemaintainedtofacilitatecleaning,
maintenanceandproperoperations
 Adequate space
 Operationsperformedindefinedareas
Receipt,storage,holding, etc.
All operations
 Penicillinoperationsinseparatearea

19. 211.44 Lighting
- Adequatelightingprovided
21 CFR, Part 210 and 211
46. Ventilation
- Adequate ventilation
- Adequateequipmentforcontrolof environment
(micro,dust, air-pressure)
- Airfiltration provided
SUB-PART 'C' – BUILDINGS AND
FACILITIES

20. SUB-PART 'C' – BUILDINGS AND
21 CFR, Part 210 and 211
FACILITIES
48. Plumbing
 Potablewatersuppliedundercontinuouspositive
pressure
 Systemfreeofdefects
 PotablewatermeetingEPA requirements(40CFR, Part
141)
 Drainsof adequate size
 Back-flowprevention

21. SUB-PART 'C' – BUILDINGS AND
21 CFR, Part 210 and 211
FACILITIES
211.50 Sewage and Refuse
 Disposeof trash,sewageandotherrefuseinasafeand
sanitary manner
52. Washing and toilet facilities
 Adequatewashingfacilitiesshallbeprovided
 Hotandcoldpotablewater
 Soapand detergent
 Airdryersorsingle-service towels
 Easyaccesstoworkingareas

22. SUB-PART 'C' – BUILDINGS AND
21 CFR, Part 210 and 211
FACILITIES
56. Sanitization
 Facilitiesshallbemaintainedinacleanandsanitary
condition
 Freeof rodents,birds, insects
 Thereshallbewrittenproceduresoncleaning
schedules,methods,equipmentandmaterials
 Shallbewrittenproceduresforrodentcides,
insecticides,fungicides
211.56 Sanitization
 Facilitiesshallbemaintainedinagoodstateof repair

23. SUB-PART 'D' – EQUIPMENT
21 CFR, Part 210 and 211
 211.63- Equipmentdesign,size, and
location
 211.65- Equipment construction
 211.67- Equipmentcleaning and
maintenance
 211.68- Automatic,mechanical,and
electronic equipment
 211.72- Filters

24. 21 CFR, Part 210 and 211
211.63 Equipment design, size and location
 Equipmentshallbeof appropriatedesign,adequate
sizeandsuitablylocatedtofacilitateoperations,
cleaningandmaintenance
65. Equipment construction
 Equipmentmaterialof constructionnotbereactivewith
product.
 Lubricants/coolantsshallnotcomeintocontactwith
producttoalterthequalityof the product
SUB-PART 'D' – EQUIPMENT

25. SUB-PART 'D' – EQUIPMENT
21 CFR, Part 210 and 211
67. Equipment cleaning and maintenance
 Equipmentandutensilsshallbecleaned,maintained
andsanitizedtopreventmalfunctionsand
contamination
 Writtenproceduresshallbeestablishedforcleaning
andmaintenanceof equipment,utensils.
 Recordsshallbekeptof maintenance,cleaning,
sanitizingand inspection.

26. SUB-PART 'D' – EQUIPMENT
21 CFR, Part 210 and 211
68.Automatic Mechanical ,EQUPMENT Electronic
computers,etc.usedinthemanufacturingareashallbe
routinelycalibrated,checkedandinspectedasper written
procedurewithretainedrecordsof calibrations, inspections,
etc.
 Computerssystemsdocumentationandvalidation
documentationshallbemaintained.
 Computersystemselectronicrecordsmustbe controlled
includingrecordsretention,backup,and security.

27. SUB-PART 'D' – EQUIPMENT
21 CFR, Part 210 and 211
72. Filters
 Shallnotreleasefibersintodrugproducts
– If fiberreleasingfiltersare necessary
• Additionalfilteringusing0.22micronmaxporosity
• 0.45if manufacturingconditionssodictate
– Useof asbestos-containingfilterisallowedonlyafter
provingtoFDA safetyoreffectivenessisnot
compromised

28. SUB-PART 'E' – CONTROL OF COMPONENTS AND DRUG
PRODUCT CONTAINERS AND Closures
21 CFR, Part 210 and 211
 211.80–genralrequirments.
 211.82- Receiptandstorageof untestedcomponents,
drugproductcontainers, andclosures.
 211.84- Testingandapprovalorrejectionof components,
drugproductcontainers, andclosures.
 211.86- Useof approvedcomponents,drugproduct
containers,and closures.
 211.87- Retestingof approvedcomponents,drug
productcontainers,andclosures.
 211.89- Rejectedcomponents,drugproduct
containers,and closures.
 211.94- Drugproductcontainersandclosures.

29. SUB-PART 'E' – CONTROL OF COMPONENTS AND DRUG
PRODUCT CONTAINERS AND Closures
21 CFR, Part 210 and 211
GENRALREQUIRMENTS…
80. Writtenproceduresshallbemadeandfollowedfor
receipt,sampling,approval, rejection.
 Handleandstoreinamannertoprevent contamination
 Baggedorboxeditemsshallbestoredoff of thefloor
andbeadequatelyspaceforcleaningand inspection
 EachLot/containershallbeidentifiedwithcodefor
eachlotreceivedandstatus(quarantined,approved,
rejected).

30. SUB-PART 'E' – CONTROL OF COMPONENTS AND DRUG
PRODUCT CONTAINERS AND Closures
21 CFR, Part 210 and 211
82. RECIPT AND STORAGE
 Shallbeexaminedvisuallyforappropriatelabelingas
tocontents,containerdamage/sealsbroken,
contamination,etcuponreceipt.
 Materialsshallbequarantineduntiltestedand
released.

31. SUB-PART 'E' – CONTROL OF COMPONENTS AND DRUG
PRODUCT CONTAINERS AND Closures
21 CFR, Part 210 and 211
84. TESTINGANDAPPROVAL/REJECTION
 Materialsshallbewithheldfromuseuntiltestedand
releasedforusebyQuality Control.
 Fromeachlotshallbesampleduponappropriate
statisticalcriteria.
 Samplescollection
 Cleanthecontainerif necessary
 Collectthesamplesindesignatedareatoprevent
contamination
 Samplesshallbeidentifiedwithlot#,date,anddone
by, etc.
 Containersmustshowsamplesweretaken

32. SUB-PART 'E' – CONTROL OF COMPONENTS AND DRUG
PRODUCT CONTAINERS AND Closures
21 CFR, Part 210 and 211
 Samplesshallbetestedoratleastoneidentification
test.
 COA of manufacturershallbeacceptableprovidedby
atleastonespecificidentificationtestbyestablishing
vendorevaluation.
 Anylotthatdoesnotmeetthespecificationsshallbe
rejected.

33. SUB-PART 'E' – CONTROL OF COMPONENTS AND DRUG
PRODUCT CONTAINERS AND Closures
21 CFR, Part 210 and 211
86. Use of approved components
 Materialsshallbeused/issuedin FIFO.
 Deviation of FIFO shall be permitted, if temporary
an
d appropriate.
87. Retesting
 Materialsshallberetestedafterstoringalongtime
mightbehaveadverseaffectonqualitydueto
exposuretoair,heatetc.
211.89 Rejected materials
 Rejectedmaterialsshallbestoredunderdesignated
areatopreventtheuseformanufacturing.

34. SUB-PART 'E' – CONTROL OF COMPONENTS AND DRUG
PRODUCT CONTAINERS AND Closures
21 CFR, Part 210 and 211
94. Drug product containersand closures
 Provideprotectionfromexternalfactorsthatcould
contaminateordeterioratedrug
 Shallnotbereactive,additiveorabsorptiveasto
adverselyeffect product
 Cleanandsuitablefor use
 Specificationandtestmethodsshallbewrittenand
followed.

35. 21 CFR, Part 210 and 211
 211.100- Writtenprocedures;deviations
 211.101- Charge-inof components
 211.103- Calculationof yield
 211.105- Equipmentidentification
 211.110- Samplingandtestingof in-process
materialsanddrugproducts
 211.111- Timelimitationson production
 211.113- Controlof microbiological
contamination
 211.115- Reprocessing
SUB-PART 'F' – PRODUCTION & PROCESS
CONTROLS

36. 100. Written procedures; deviations
 Writtenproceduresshallbeestablishedandfollowed
forProduction(BMR) andprocesscontrols(in-process,
Intermediate spec.)
 Processcontrolfunctionsshallberecordedatthetime
of performance.
 Anydeviationfromtheestablishedprocedureshallbe
recordedand justified.
21 CFR, Part 210 and 211
SUB-PART 'F' – PRODUCTION & PROCESS
CONTROLS
SUB-PART 'F' – PRODUCTION & PROCESS
CONTROLS

37. SUB-PART 'F' – PRODUCTION & PROCESS
CONTROLS
21 CFR, Part 210 and 211
211.101 Charge-in of components
 Eachbatchformulationshouldattempttomake100%of
specifiedactive ingredient
 Componentsformanufacturingshallbeweighed,
measured,orsubdividedasappropriateandshouldbe
verifiedbysecond person.
 QC released/approved
 Weight/measurementiscorrectperbatch record
 Containersareproperly identified

38. SUB-PART 'F' – PRODUCTION & PROCESS
CONTROLS
21 CFR, Part 210 and 211
 Whenacomponentistransferredtoanon-original
container,itshallindicate
– Name,item code
– Receiving/controlnumber
– Weight/measurementinnewcontainer
– Batchforwhichcomponentwasissuedincluding
name,strengthandlotnumber
 Eachcomponentaddedtothebatchshallbeverifiedby
thesecondperson.

39. SUB-PART 'F' – PRODUCTION & PROCESS
CONTROLS
21 CFR, Part 210 and 211
211.103 Calculation of yield
 Actualyieldsandpercentagesof theoreticalyieldshall
bedeterminedattheconclusionof eachstageof
manufacturing,processing,packaging,orholdingof the
drug product.
 Suchcalculationsshalleitherbeperformedbyone
person and independentlyverified by a second person.

40. SUB-PART 'F' – PRODUCTION & PROCESS
CONTROLS
21 CFR, Part 210 and 211
211.105 Equipment identification
 Storagecontainers,processinglines,andmajor
equipmentusedduringtheproductionshallbeproperly
identified.
 Major equipment shall be identified by number or code
thatshall be recorded in the batchproduction record to
showthespecificequipmentused.

41. 211.110 Sampling and testing of in-process
materials….
21 CFR, Part 210 and 211
SUB-PART 'F' – PRODUCTION & PROCESS
CONTROLS
Inprocessofspecificationsshallbeconsistentwithfinal
specifications
 In-processmaterialstestedforID, quality,strengthand
purityandbeacceptedorrejectedbyQC
Rejectedmaterialshallbequarantinedinorderto
preventusein manufacturing

42. SUB-PART 'F' – PRODUCTION & PROCESS
CONTROLS
21 CFR, Part 210 and 211
211.111 Time limitations on production
 Whenappropriate,timelimitsforthecompletionof each
phaseof productionshallbeestablishedtoassurethe
qualityof theproduct.
 Deviationfromestablishedtimelimitsmaybe
acceptableif suchdeviationdoesnotcompromisethe
qualityof thedrugproduct.Suchdeviationshallbe
justifiedanddocumented.

43. SUB-PART 'F' – PRODUCTION & PROCESS
CONTROLS
21 CFR, Part 210 and 211
211.113 Control of microbiological contamination
 Written procedures shall be established and followed to
prevent objectionable microorganisms in drug products
of non-sterile.
 Writtenproceduresshallbeestablishedandfollowedto
preventmicrobiologicalcontaminationintosteriledrug
products.
 Suchproceduresshallincludevalidation.

44. SUB-PART 'F' – PRODUCTION & PROCESS
CONTROLS
21 CFR, Part 210 and 211
211.115 Reprocessing
 Writtenproceduresshallbeestablishedfor
reprocessingthebatchesthatdonotconformto
standardsor specifications.
 Writtenproceduresshallbeestablishedforthestepsto
betakentoinsurethatthereprocessedbatcheswithwill
conformallestablishedstandards,specifications,and
characteristics.
 Reprocessingshallnotbeperformedwithoutthereview
andapprovalbythequality unit.

45. SUB-PART 'G' – PACKAGING AND LABELING
CONTROL
21 CFR, Part 210 and 211
 211.122Materialsexaminationandusagecriteria
 211.125Labeling issuance
 211.130Packagingandlabelingoperations
 211.132Tamper-resistantpackaging
requirementsforOTC humandrug products
 211.134Drugproduct inspection
 211.137Expiration dating

46. SUBPART G – PACKAGING AND LABELING
CONTROL
21 CFR, Part 210 and 211
211.122 Materials examination and usage criteria
 Writtenproceduresshallbeestablishedandfollowedfor
receipt,identification,storage,handling,sampling,testingof
Labelingandpackaging materials
 Materialsnotmeetingspecificationsshouldbe rejected.
 Recordsshouldbemaintainedwiththedetailsof receipt,
examinationandapproved/rejected
 Labelsshouldbestoredseparatelyforeachproductand
accesswillbelimitedtoauthorized personnel

47. SUB-PART 'G' – PACKAGING AND LABELING
CONTROL
21 CFR, Part 210 and 211
 Obsoleteandoutdatedlabelsshallbe destroyed
 Visualinspectionshallbedoneforcorrectlabelingduringor
aftercompletionof finishingoperationsshallbeperformed
byonepersonandindependentlyverifiedbyasecond
person.

48. SUB-PART 'G' – PACKAGING AND LABELING
CONTROL
21 CFR, Part 210 and 211
211.125 Labeling issuance
 Strictcontrolshallbeexercisedoverlabelingissuedforuse
 Compareissuedmaterialstomaster
 Reconciliationof labelsshouldbe maintain
 Allexcesslabelingbearinglotorcontrolnumbersshallbe
destroyed
 Writtenproceduresshallbeestablishedandfollowedforthe
issuanceoflabeling
 Returnedmaterialsshallbestoredseparatelytoprevent
mix-ups

49. SUB-PART 'G' – PACKAGING AND LABELING
CONTROL
21 CFR, Part 210 and 211
211.130 Packaging and labeling operations
 Writtenproceduresshallbeestablishedandfollowedfor
PackagingandLabelingoperations,procedureshallcoverthe
following
 Preventionof mix-ups &contamination
 Identificationandhandlingof setasidefilledbutunlabeled
product.
 Identification of thedrug product witha lotor control
 Examinationof packagingandlabelingmaterialsfor
suitabilityandcorrectnessbeforepackaging operations
 Inspectionof packagingandlabelingfacilitiestoensurethe
previousproductsareremovedand cleaned

50. SUB-PART 'G' – PACKAGING AND LABELING
CONTROL
21 CFR, Part 210 and 211
211.134 Drug product inspection
 Packagedandlabeledproductshouldbefinalinspectedto
assurecorrect labeling
 Asamplingof unitsshallbecollectedandinspectedforcorrect
labeling
 Resultsof inspectionshallberecordedinbatchrecord

51. SUB-PART 'G' – PACKAGING AND LABELING
CONTROL
21 CFR, Part 210 and 211
211.137 Expiration dating
 Expirationdateshouldbedeterminedbystabilitytesting
 Labelshallbereflectthestorageconditiondeterminedby
stability testing
 Expirationdateshallbebearonlabelfortheproductstobe
reconstitutedandun-reconstituted
 Expirationdatesmustbereflecton labeling

52. SUB-PART 'H'– HOLDING AN DISTRIBUTION
21 CFR, Part 210 and 211
 211.142- Warehousing procedures
 211.150- Distributionprocedures

53. SUB-PART 'H' – HOLDING AND DISTRIBUTION
21 CFR, Part 210 and 211
211.142 Warehousing procedures
 Quarantineof drugproductsbeforereleasebythequalitycontrol
unit
 Storageof drugproductsunderappropriateconditionswhich
maynotaffectthe quality/strength
211.150 Distribution procedures
 Oldestproductsaredistributedfirst.
 Deviationispermittedif itistemporaryandappropriate
 Distributionrecordsshouldbemaintaintofacilitaterecallif
required/necessary.

54. SUB-PART 'I' – LABORATORY CONTROLS
21 CFR, Part 210 and 211
 211.160- General requirements
 211.165- Testingandreleasefordistribution
 211.166- Stabilitytesting
 211.167- Specialtesting requirements
 211.170- Reserve samples
 211.173- Laboratoryanimals
 211.176- Penicillin contamination.

55. 211.160 General requirements
 Writtenprocedureshallbeestablishedandfollowedfor
specification,testprocedures,samplingandscientifically sound.
 Anydeviationfromestablishedshallberecorded, justified
 Instrumentscalibrationsshouldbeperformedasperprocedures
and schedules
 Instrumentswhicharefaileddonnotuse.
21 CFR, Part 210 and 211
SUB-PART 'I' – LABORATORY CONTROLS

56. 211.165 Testing and release for distribution
 Everybatchshouldmeetthespecificationpriortorelease
 Samplingandtestingplansshouldbedescribedinwritten
procedure
 Validatedmethodshouldbeemployedfor testing
 Anybatch,notmetthespecificationshallbe rejected.
21 CFR, Part 210 and 211
SUB-PART 'I' – LABORATORY CONTROLS

57. 
21 CFR, Part 210 and 211
Writtenprocedureshouldbeavailablewiththefollowingdetails
 Sampledetails(Quantity,batch# etc.)
 Testing interval
 Stabilityconditions
 Stabilityspecifications
211.166 Stability testing
 Stabilitystudiesshouldbeperformed.
 Stabilitysampleshouldbesimulatedtothemarket
SUB-PART 'I' – LABORATORY CONTROLS

58. 211.170 Reserve sample
 Representativeof eachbatchsampleshallberetained.
 Samplequantityconsistsof twocompleteanalysis
 Sampleshouldbesimulatedtothe market
 Sampleshouldberetainedupto1yearafter expiration.
 Sampleshouldbeexaminedvisuallyonceinayearforany
deteriorationandtorecorded
21 CFR, Part 210 and 211
SUB-PART 'I' – LABORATORY CONTROLS

59. SUB-PART 'I' – LABORATORY CONTROLS
21 CFR, Part 210 and 211
211.173 Laboratory animals
 Animalsusedintestingcomponentsshallbemaintainedand
controlledinamannerthatassurestheirsuitabilityfortheir
intended use.
 Theyshallbeidentified,andadequaterecordsshallbe
maintainedshowingthehistoryof their use.
211.176 Penicillin contamination
 Penicillincontrolledinseparatefacility
 If,exposedtopenicillin,theproductshallbetestedforthe
presenceof penicillin.Suchdrugproductshallnotbemarketed
untiltheycompliesas perFDA requirements.

60. SUB-PART 'J' – RECORDS AND REPORTS
21 CFR, Part 210 and 211
 211.180- General requirements
 211.182- Equipmentcleaninganduselog
 211.184- Component,drugproductcontainer,
closure,andlabeling records
 211.186- Masterproductionandcontrol
records
 211.188- Batchproductionandcontrolrecords
 211.192- Productionrecord review
 211.194- Laboratoryrecords
 211.196- Distributionrecords
 211.198- Complaintfiles

61. 211.180 General Requirements
 Recordsshallberetainedforatleast1yearaftertheexpiration
date
 Allrecordsorcopiesof suchrecordsshallbereadilyavailable
for review/inspection
 Productqualityreviewshouldbeperformedonceina year
 Proceduresshouldbeestablishedtoassurethatmanagement
are notified of investigations,recallsand FDA issues
21 CFR, Part 210 and 211
SUB-PART 'J‘ – RECORDS AND REPORTS

62. SUB-PART 'J' – RECORDS AND REPORTS
21 CFR, Part 210 and 211
211.182 Equipment cleaning and use log
 Equipmentusagerecordsshouldbe maintain.
211.184 Container, closure, and labeling records
 Recordsshallbemaintain,including
 Suppliernameandlotnumber
 Dateof receipt
 Approved/Rejected
 Labelshallbecomparedwith master

63. 211.186 Master production and control records
 Masterproductionandcontrolrecordsshallbemaintain
 Madebyonepersonandcheckedbyanother(prepared,dated,
signed– full signature)
 Completelistofcomponents
 Accuratestatementof weights,reasonable variations
 Theoreticalreconciliation
21 CFR, Part 210 and 211
SUB-PART 'J' – RECORDS AND REPORTS

64. 211.188 Batch production and control records
 Batchproductionandcontrolrecordsshallbemaintain,includes
 Operationdates&Equipmentsused
 Listof materialsandquantities
 In-processresults
 Actualyield&Theoreticalyield
 Deviations
 Doneby&Checkedby sign
21 CFR, Part 210 and 211
SUB-PART 'J' – RECORDS AND REPORTS

65. 211.192 Production record review
 Batchrecordsincludingpackagingandlabeling,shallbe
reviewedandapprovedpriorto release.
 If anybatchfailedtomeetthespecificationsshallbe
investigatedand recorded.
 Theinvestigationshallextendtootherbatches… thatmayhave
beenassociatedwiththespecificfailureor discrepancy
 Awrittenrecordof theinvestigationshallbemadeandshall
includetheconclusionsand follow-up.
21 CFR, Part 210 and 211
SUB-PART 'J'– RECORDS AND REPORTS

66. •
•
•
•
•
•
•
21 CFR, Part 210 and 211
Descriptionof samplereceived
Statementof eachmethod
Completerecordof alldata– graphs,charts
Initialsof persondoingtestand dates
Initialsof personcheckinganddates
Calibrationdata maintained
Stabilityrecords maintained
211.194 Laboratory records
 Labrecordsincludecompletedatafromalltests
SUB-PART 'J' – RECORDS AND REPORTS

67. SUB-PART J – RECORDS AND REPORTS
21 CFR, Part 210 and 211
211.196 Distribution records
 Distributionrecordsshallbemaintained
– Who, where,what,quantity
211.198 Compliant files
 Complaintfilesshallbemaintained
– Investigationsperformed
- Includenameof product,lotnumber,nameof
complainant,natureof complaint,reply

68.  211.204- Returneddrug products
 211.208- Drugproduct salvaging
21 CFR, Part 210 and 211
SUB-PART ‘K'– RETURNED AND SALVAGED DRUG
PRODUCTS

69. SUB-PART 'K' – RETURNED AND SALVAGED DRUG
PRODUCTS
21 CFR, Part 210 and 211
211.204 Returned drug products
 Returnedproductsidentifiedandheld
 If conditionsof returnorstorageareindoubt,
investigationiswarranted
 Proceduresshallbeinwriting

70. SUB-PART 'K' – RETURNED AND SALVAGED DRUG
PRODUCTS
21 CFR, Part 210 and 211
211.208 Drug product salvaging
 Productsubjectedtoimproperstorageconditionsdue
todisasteroraccidentshallnotbesalvaged
 Unless,
Testscanshoweverythingis OK
Evaluationof conditionsindicatesproductwasnot
exposedtosuchharshconditions

71. ThankYo
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