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 Part	Subpart	Title	Section
210	NA	Current Good Manufacturing Practice In Manufacturing, Processing, Packing, or Holding Of Drugs; General	Status Applicability Definitions
211	NA	Current Good Manufacturing Practice for Finished Pharmaceuticals
	Subpart B	Organization and Personnel	Responsibilities of quality control unit Personnel qualifications Personnel responsibilities Consultants
	Subpart C	Buildings and Facilities	Design and construction features Lighting Ventilation, air filtration, air heating and cooling Plumbing Sewage and refuse Washing and toilet facilities Sanitation Maintenance
	Subpart D	Equipment	Equipment design, size and location Equipment construction Equipment cleaning and maintenance Automatic, mechanical and electronic equipment Filters
	Subpart E	Control of Components and Drug Product Containers and Closures	General 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 F	Production and Process Controls	Written 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 Reprocessing
	Subpart G	Packaging and Labeling Control	Material 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 H	Holding and Distribution	Warehousing procedures Distribution procedures
	Subpart I	Laboratory Controls	General requirements Testing and release for distribution Stability testing Special testing requirements Reserve samples Laboratory animals Penicillin contamination
	Subpart J	Records and Reports	General 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 K	Returned and Salvaged Drug Products	Returned drug products Drug product salvaging
600	NA	Biological Products: General
	Subpart B	Establishment Standards	Personnel Physical establishment, equipment, animals and care Records Retention samples Reporting of biological product deviations by licensed manufacturers Temperatures during shipment
606	NA	Current Good Manufacturing Practice for Blood And Blood Components
	Subpart B	Organization and Personnel	Personnel
	Subpart C	Plant and Facilities	Facilities
	Subpart D	Equipment	Equipment Supplies and reagents
	Subpart F	Production and Process Controls	Standard operating procedures Plateletpheresis, leukapheresis and plasmapheresis
	Subpart G	Additional Labeling Standards for Blood and Blood Components	Labeling, general requirements Container label Circular of Information
	Subpart H	Laboratory Controls	Laboratory controls Compatibility testing
	Subpart I	Records and Reports	Records Distribution and receipt Procedures and records Adverse reaction file Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments and transfusion services
820	NA	Quality System Regulations
	Subpart B	Quality System Regulations	Management responsibility Quality audit Personnel
	Subpart C	Design Controls	Design controls
	Subpart D	Document Controls	Document controls
	Subpart E	Purchasing Controls	Purchasing controls
	Subpart F	Identification and Traceability	Identification Traceability
	Subpart G	Production and Process Controls	Production and process controls Inspection, measuring and test equipment Process validation
	Subpart H	Acceptance Activities	Receiving, in-process and finished device acceptance Acceptance status
	Subpart I	Nonconforming Product	Nonconforming product
	Subpart J	Corrective and Preventive Action	Corrective and preventive action
	Subpart K	Labeling and Packaging Control	Device labeling Device packaging
	Subpart L	Handling, Storage, Distribution and Installation	Handling Storage Distribution Installation
	Subpart M	Records	General requirements Device master record Device history record Quality system record Complaint files
	Subpart N	Servicing	Servicing
	Subpart O	Statistical techniques	Statistical techniques

Current Good Manufacturing Practice

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