What is Mean by 21 CFR Part 210 and Part 211

This article provide information about 21 CFR Part 210 and Part 211.

What is mean by CFR ?

CFR stands for “Code of Federal Regulations.” It is a set of regulations, rules, and administrative procedures that have the force of law in the United States. The Title/ Volume of the CFR is revised annually i.e. once on each calendrer year  by the Office of the Federal Register, and it contains the complete and official text of federal regulations that have been issued by federal agencies.

What is mean by the Part 211 and 210,

21 CFR part 210 and 211 are specific parts of the Code of Federal Regulations that contain regulations related to pharmaceutical manufacturing, processing, and packaging in the United States.

21 CFR part 210 :

21 CFR part 210 contains  Current Good Manufacturing Practice (CGMP) regulations requirements and general provisions for Manufacturing, Processing, Packing or Handling of drugs.

 21 CFR part 211 :

21 CFR part 211 also known as the Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, establishes minimum requirements for the methods, facilities, and controls used in the manufacture, processing, and packaging of finished pharmaceutical products. These regulations apply to all aspects of the manufacturing process, including equipment, personnel, sanitation, record-keeping, Testing .

Bifurcation of each filed of 21 CFR Part 210 and part 211

TITLE 21 : Food and Drugs
CHAPTER I : Food and Drug Administration Department of Health and Human Services
SUBCHAPTER C : Drugs: General
FR : Federal Regulations
Part 210 : Current Good Manufacturing Practice In Manufacturing, Processing, Packing or Holding of Drugs; General
Part 211 : Current Good Manufacturing Practice For Finished Pharma

Part and Subpart  Contents of  21 CFR Part 210 :

21 CFR PART 210 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL

210.1 – Status of current good manufacturing practice regulations.

210.2 – Applicability of current good manufacturing practice regulations.

210.3 – Definitions.

Part and Subpart  Contents of  21 CFR Part 211 :

PART 211 :  CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

Subpart A – General Provisions
211.1 – Scope.
211.3 – Definitions.

Subpart B – Organization and Personnel
211.22 – Responsibilities of quality control unit.
211.25 – Personnel qualifications.
211.28 – Personnel responsibilities.
211.34 – Consultants.

Subpart C – Buildings and 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.

Subpart 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.

Subpart 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.

Subpart F – Production and Process Controls
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.

Subpart G – Packaging and 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.

Subpart H – Holding and Distribution
211.142 – Warehousing procedures.
211.150 – Distribution procedures.

Subpart 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.

Subpart J – Records and 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.

Subpart K – Returned and Salvaged Drug Products
211.204 – Returned drug products.
211.208 – Drug product salvaging.

For detailed Information and description for 21 CFR part 210 and 211, Plz click on below link.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=210

For detailed Information and description for 21 CFR part 211 Plz click on below link.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211