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 |
REGULATORY UPDATE: FDA Issues Draft Guidance to Support CGT Development
November 19, 2024
AABB Accepting Feedback on Cell and Gene Therapy Standards for Pharmacy
November 19, 2024
FDA Approves Direct-to-Brain Gene Therapy for AADC Deficiency
November 14, 2024
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