21 CFR Part 211 — Current Good Manufacturing Practice
Title 21 Code of Federal Regulations Part 211 establishes the minimum current good manufacturing practice (cGMP) requirements for the preparation of drug products (finished pharmaceuticals) for administration to humans or animals. Covers all aspects of pharmaceutical manufacturing from personnel and facilities to production controls and record keeping. Enforced by the FDA.
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Framework Domains (11)
Subpart A — General Provisions
Scope, definitions, and applicability of cGMP requirements
| Code | Title |
|---|---|
| CFR211-A-1 | Section 211.1 — Scope |
| CFR211-A-3 | Section 211.3 — Definitions |
Subpart B — Organization and Personnel
Quality control unit responsibilities, personnel qualifications, and consultants
| Code | Title |
|---|---|
| CFR211-B-22 | Section 211.22 — Responsibilities of Quality Control Unit |
| CFR211-B-25 | Section 211.25 — Personnel Qualifications |
| CFR211-B-28 | Section 211.28 — Personnel Responsibilities |
| CFR211-B-34 | Section 211.34 — Consultants |
Subpart C — Buildings and Facilities
Design, construction, lighting, ventilation, and plumbing requirements for manufacturing facilities
| Code | Title |
|---|---|
| CFR211-C-42 | Section 211.42 — Design and Construction Features |
| CFR211-C-44 | Section 211.44 — Lighting |
| CFR211-C-46 | Section 211.46 — Ventilation, Air Filtration, Air Heating and Cooling |
| CFR211-C-48 | Section 211.48 — Plumbing |
| CFR211-C-50 | Section 211.50 — Sewage and Refuse |
| CFR211-C-56 | Section 211.56 — Sanitation |
| CFR211-C-58 | Section 211.58 — Maintenance |
Subpart D — Equipment
Equipment design, size, construction, cleaning, and maintenance requirements
| Code | Title |
|---|---|
| CFR211-D-63 | Section 211.63 — Equipment Design, Size, and Location |
| CFR211-D-65 | Section 211.65 — Equipment Construction |
| CFR211-D-67 | Section 211.67 — Equipment Cleaning and Maintenance |
| CFR211-D-68 | Section 211.68 — Automatic, Mechanical, and Electronic Equipment |
| CFR211-D-72 | Section 211.72 — Filters |
Subpart E — Control of Components and Drug Product Containers/Closures
Receipt, identification, storage, testing, and approval of components, containers, and closures
| Code | Title |
|---|---|
| CFR211-E-80 | Section 211.80 — General Requirements |
| CFR211-E-82 | Section 211.82 — Receipt and Storage of Untested Components |
| CFR211-E-84 | Section 211.84 — Testing and Approval or Rejection of Components |
| CFR211-E-86 | Section 211.86 — Use of Approved Components |
| CFR211-E-94 | Section 211.94 — Drug Product Containers and Closures |
Subpart F — Production and Process Controls
Written procedures, charge-in controls, process validation, and time limitations
| Code | Title |
|---|---|
| CFR211-F-100 | Section 211.100 — Written Procedures and Deviations |
| CFR211-F-101 | Section 211.101 — Charge-in of Components |
| CFR211-F-103 | Section 211.103 — Calculation of Yield |
| CFR211-F-105 | Section 211.105 — Equipment Identification |
| CFR211-F-110 | Section 211.110 — Sampling and Testing of In-Process Materials and Drug Products |
| CFR211-F-111 | Section 211.111 — Time Limitations on Production |
| CFR211-F-113 | Section 211.113 — Control of Microbiological Contamination |
| CFR211-F-115 | Section 211.115 — Reprocessing |
Subpart G — Packaging and Labeling Control
Materials examination, labeling issuance, packaging operations, and tamper-resistant requirements
| Code | Title |
|---|---|
| CFR211-G-122 | Section 211.122 — Materials Examination and Usage Criteria |
| CFR211-G-125 | Section 211.125 — Labeling Issuance |
| CFR211-G-130 | Section 211.130 — Packaging and Labeling Operations |
| CFR211-G-132 | Section 211.132 — Tamper-Resistant Packaging Requirements |
| CFR211-G-134 | Section 211.134 — Drug Product Inspection |
| CFR211-G-137 | Section 211.137 — Expiration Dating |
Subpart H — Holding and Distribution
Warehousing, storage conditions, and distribution procedures
| Code | Title |
|---|---|
| CFR211-H-142 | Section 211.142 — Warehousing Procedures |
| CFR211-H-150 | Section 211.150 — Distribution Procedures |
Subpart I — Laboratory Controls
Testing and release specifications, stability testing, special testing requirements, and reserve samples
| Code | Title |
|---|---|
| CFR211-I-160 | Section 211.160 — General Requirements |
| CFR211-I-165 | Section 211.165 — Testing and Release for Distribution |
| CFR211-I-166 | Section 211.166 — Stability Testing |
| CFR211-I-167 | Section 211.167 — Special Testing Requirements |
| CFR211-I-170 | Section 211.170 — Reserve Samples |
| CFR211-I-173 | Section 211.173 — Laboratory Animals |
| CFR211-I-176 | Section 211.176 — Penicillin Contamination |
Subpart J — Records and Reports
Batch production records, distribution records, complaint files, and record retention
| Code | Title |
|---|---|
| CFR211-J-180 | Section 211.180 — General Requirements |
| CFR211-J-182 | Section 211.182 — Equipment Cleaning and Use Log |
| CFR211-J-184 | Section 211.184 — Component, Drug Product Container, Closure, and Labeling Records |
| CFR211-J-186 | Section 211.186 — Master Production and Control Records |
| CFR211-J-188 | Section 211.188 — Batch Production and Control Records |
| CFR211-J-192 | Section 211.192 — Production Record Review |
| CFR211-J-194 | Section 211.194 — Laboratory Records |
| CFR211-J-196 | Section 211.196 — Distribution Records |
| CFR211-J-198 | Section 211.198 — Complaint Files |
Subpart K — Returned and Salvaged Drug Products
Procedures for handling returned and salvaged drug products
| Code | Title |
|---|---|
| CFR211-K-204 | Section 211.204 — Returned Drug Products |
| CFR211-K-208 | Section 211.208 — Drug Product Salvaging |
Maps to 486 other frameworks
Frequently Asked Questions
What is 21 CFR Part 211 — Current Good Manufacturing Practice?
21 CFR Part 211 — Current Good Manufacturing Practice is a compliance framework from United States with 11 domains and 57 controls. Title 21 Code of Federal Regulations Part 211 establishes the minimum current good manufacturing practice (cGMP) requirements for the preparation of drug products (finished pharmaceuticals) for administration to humans or animals. Covers all aspects of pharmaceutical manufacturing from personnel and facilities to production controls and record keeping. Enforced by the FDA. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
How many controls does 21 CFR Part 211 — Current Good Manufacturing Practice have?
21 CFR Part 211 — Current Good Manufacturing Practice has 57 controls organised across 11 domains. The largest domains are Subpart J — Records and Reports (9 controls), Subpart F — Production and Process Controls (8 controls), Subpart C — Buildings and Facilities (7 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
What frameworks does 21 CFR Part 211 — Current Good Manufacturing Practice map to?
21 CFR Part 211 — Current Good Manufacturing Practice maps to 486 other compliance frameworks. The top mapping partners are FDA Quality Management System Regulation (QMSR) (14% coverage), US OFAC Sanctions Compliance Framework (12% coverage), CFTC System Safeguards (17 CFR 37, 38, 39, 49) (9% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I get started with 21 CFR Part 211 — Current Good Manufacturing Practice compliance?
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