Current Good Manufacturing Practice

Cellular therapy products regulated as biological products are subject to Current Good Manufacturing Practice (CGMP) regulations, in addition to specific regulations in 21 CFR 1271. The CGMP regulations are in 21 CFR Parts 210, 211, 600, 606 and 820. CGMP topics addressed in these parts are provided below.

21 CFR PartSubpartTitle Section
210 NACurrent Good Manufacturing Practice In Manufacturing, Processing, Packing, or Holding Of Drugs; GeneralStatus
211 NACurrent Good Manufacturing Practice for Finished Pharmaceuticals 
 Subpart BOrganization and PersonnelResponsibilities of quality control unit
Personnel qualifications
Personnel responsibilities
 Subpart CBuildings and FacilitiesDesign and construction features
Ventilation, air filtration, air heating and cooling
Sewage and refuse
Washing and toilet facilities
 Subpart DEquipmentEquipment design, size and location
Equipment construction
Equipment cleaning and maintenance
Automatic, mechanical and electronic equipment
 Subpart EControl of Components and Drug Product Containers and ClosuresGeneral requirements
Receipt and storage of untested components, drug product containers and closures
Testing and approval or rejection of components, drug product containers and closures
Use of approved components, drug product containers and closures
Retesting of approved components, drug product containers and closures
Rejected components, drug product containers and closures
Drug product containers and closures
 Subpart FProduction and Process ControlsWritten procedures; deviations
Charge-in of components
Calculation of yield
Equipment identification
Sampling and testing of in-process materials and drug products
Time limitations on production
Control of microbiological contamination
 Subpart GPackaging and Labeling ControlMaterial examination and usage criteria
Labeling issuance
Packaging and labeling operations
Tamper-evident packaging requirements for over-the-counter (OTC) human drug products
Drug product inspection
Expiration dating
 Subpart HHolding and DistributionWarehousing procedures
Distribution procedures
 Subpart ILaboratory ControlsGeneral requirements
Testing and release for distribution
Stability testing
Special testing requirements
Reserve samples
Laboratory animals
Penicillin contamination
 Subpart JRecords and ReportsGeneral requirements
Equipment cleaning and use log
Component, drug product container, closure and labeling records
Master production and control records
Batch production and control records
Production record review
Laboratory records
Distribution records
Complaint files
 Subpart KReturned and Salvaged Drug ProductsReturned drug products
Drug product salvaging
600 NABiological Products:  General 
 Subpart BEstablishment StandardsPersonnel
Physical establishment, equipment, animals and care
Retention samples
Reporting of biological product deviations by licensed manufacturers
Temperatures during shipment
606 NACurrent Good Manufacturing Practice for Blood And Blood Components 
 Subpart BOrganization and PersonnelPersonnel
 Subpart CPlant and FacilitiesFacilities
 Subpart DEquipmentEquipment
Supplies and reagents
 Subpart FProduction and Process ControlsStandard operating procedures
Plateletpheresis, leukapheresis and plasmapheresis
 Subpart GAdditional Labeling Standards for Blood and Blood ComponentsLabeling, general requirements
Container label
Circular of Information
 Subpart HLaboratory ControlsLaboratory controls
Compatibility testing
 Subpart IRecords and ReportsRecords
Distribution and receipt
Procedures and records
Adverse reaction file
Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments and transfusion services
820 NAQuality System Regulations 
 Subpart BQuality System RegulationsManagement responsibility
Quality audit
 Subpart CDesign ControlsDesign controls
 Subpart DDocument ControlsDocument controls
 Subpart EPurchasing ControlsPurchasing controls
 Subpart FIdentification and TraceabilityIdentification
 Subpart GProduction and Process ControlsProduction and process controls
Inspection, measuring and test equipment
Process validation
 Subpart HAcceptance ActivitiesReceiving, in-process and finished device acceptance
Acceptance status
 Subpart INonconforming ProductNonconforming product
 Subpart JCorrective and Preventive ActionCorrective and preventive action
 Subpart KLabeling and Packaging ControlDevice labeling
Device packaging
 Subpart LHandling, Storage, Distribution and InstallationHandling
 Subpart MRecordsGeneral requirements
Device master record
Device history record
Quality system record
Complaint files
 Subpart NServicingServicing
 Subpart OStatistical techniquesStatistical techniques