21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals

21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals

FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations.  The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.  The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.

Code of Federal Regulations (CFR).  FDA's portion of the CFR is in Title 21, which interprets the Federal Food, Drug and Cosmetic Act and related statutes, including the Public Health Service Act.

• 21 CFR Part 314 and Part 600 - Application and licensing submission requirements for new and generic drug applicants.
• 21 CFR Part 210 - Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs.
• 21 CFR Part 211- Current Good Manufacturing Practice for Finished Pharmaceuticals.

21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals

Subpart	Clause
A. General Provisions	-
B. Organization & Personnel	211.22 Responsibilities of Quality control unit
	211.25 Personnel Qualifications
	211.28 Personnel Responsibilities
	211.34 Consultants
C. Building  & Facilities	211.42 Design and construction features
	211.44 Lighting
	211.46 Ventilation, air filtration, air heating and cooling
	211.48 Plumbing
	211.50 Sewage and refuse
	211.52 Washing and toilet facilities
	211.56 Sanitation
	211.58 Maintenance
D. Equipment	211.63 Equipment design, size and location
	211.65 Equipment construction
	211.67 Equipment cleaning and maintenance
	211.68 Automatic, mechanical and electronic equipment
	211.72 Filters
E. Control of components and Drug product containers and closures	211.80 General requirements
	211.82 Receipt and storage of untested components, drug product containers and closures
	211.84 Testing and approval or rejection of components, drug product containers and closures
	211.86 Use of approved components, drug product containers and closures
	211.87 Retesting of approved components, drug product containers and closures
	211.89 Rejected components, drug product containers and closures
	211.94 Drug product containers and closures
F. Production & Process Control	211.100 Written procedures; deviations
	211.101 Charge-in of components
	211.103 Calculation of yield
	211.105 Equipment identification
	211.110 Sampling and testing of in-process materials and drug products
	211.111 Time limitations on production
	211.113 Control of microbiological contamination
	211.115 Reprocessing
G. Packaging & labeling Control	211.122 Materials examination and usage criteria
	211.125 Labeling issuance
	211.130 Packaging and labeling operations
	211.132 Tamper evident packaging requirements for over the counter (OTC) human drug products
	211.134 Drug product inspection
	211.137 Expiration Dating
H. Holding & distribution	211.142 Warehousing procedures
	211.150 Distribution procedures
I. Laboratory Controls	211.160 General requirements
	211.165 Testing and release for distribution
	211.166 Stability testing
	211.167 Special testing requirements
	211.170 Reserve samples
	211.173 Laboratory animals
	211.176 Penicillin contamination
J. Records & reports	211.180 General requirements.
	211.182  Equipment cleaning and use log
	211.184 Component, drug product container, closure, and labeling records
	211.186 Master production and control records
	211.188 Batch production and control records
	211.192 Production record review
	211.194 Laboratory records
	211.196 Distribution records
	211.198 Complaint files
K. Returned and salvaged drug products	211.204 Returned drug products
	211.208 Drug product salvaging

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