CFR — Code of Federal Regulations Title 21 Part 211

TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C – DRUGS: GENERAL

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.

As per US Health & Human Services, the information on this page is current as of Aug. 30 2024.