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21 CFR Part 211 - Current Good Manufacturing Practice
United States
v2024
21 domains
78 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.
Verified
Framework summaries on this platform are AI-assisted interpretations for educational and compliance planning purposes. They do not reproduce or replace the official standards. Refer to the authoritative source for the definitive text. Framework names and trademarks belong to their respective organisations.
Framework Domains (21)
Buildings and Facilities
2 controls
| Code | Title |
|---|---|
| 211.42 | Design and Construction of Buildings |
| 211.46 | Ventilation, Air Filtration, Air Heating and Cooling |
Control of Components
1 controls
| Code | Title |
|---|---|
| 211.84 | Testing and Approval of Components |
Equipment
2 controls
| Code | Title |
|---|---|
| 211.67 | Equipment Cleaning and Maintenance |
| 211.68 | Automatic, Mechanical, and Electronic Equipment |
Holding and Distribution
2 controls
| Code | Title |
|---|---|
| 211.142 | Warehousing Procedures |
| 211.150 | Distribution Procedures |
Laboratory Controls
2 controls
| Code | Title |
|---|---|
| 211.165 | Testing and Release for Distribution |
| 211.166 | Stability Testing |
Organization and Personnel
3 controls
| Code | Title |
|---|---|
| 211.22 | Responsibilities of Quality Control Unit |
| 211.25 | Personnel Qualifications |
| 211.28 | Personnel Responsibilities and Hygiene |
Packaging and Labeling Control
2 controls
| Code | Title |
|---|---|
| 211.122 | Materials Examination and Usage Criteria |
| 211.130 | Packaging and Labeling Operations |
Production and Process Controls
3 controls
| Code | Title |
|---|---|
| 211.100 | Written Procedures for Production and Process Control |
| 211.110 | Sampling and Testing of In-Process Materials |
| 211.113 | Control of Microbiological Contamination |
Records and Reports
2 controls
| Code | Title |
|---|---|
| 211.180 | General Records Requirements |
| 211.192 | Production Record Review |
Returned and Salvaged Drug Products
2 controls
| Code | Title |
|---|---|
| 211.198 | Complaint Files |
| 211.204 | Returned Drug Products |
Subpart A - General Provisions
2 controls
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
4 controls
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
7 controls
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
5 controls
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
5 controls
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
8 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
6 controls
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
2 controls
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
7 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
9 controls
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
2 controls
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 |
Your Compliance Coverage
If you comply with 21 CFR Part 211 - Current Good Manufacturing Practice, you already cover:
21 CFR Part 58 - Good Laboratory Practice (GLP)
21%
16 controls mapped
Compare →FDA Quality Management System Regulation (QMSR)
10%
8 controls mapped
Compare →PIC/S Guide to Good Manufacturing Practice for Medicinal Products
6%
5 controls mapped
Compare →+ 195 more: NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements (6%), BRCGS Global Standard for Food Safety Issue 9 (6%)
See all 198 mapped frameworks ↓Maps to 198 other frameworks
78 total controls
21 CFR Part 58 - Good Laboratory Practice (GLP)
16 source controls mapped|23 target controls covered
21%
FDA Quality Management System Regulation (QMSR)
8 source controls mapped|4 target controls covered
10%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
5 source controls mapped|5 target controls covered
6%
NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
5 source controls mapped|9 target controls covered
6%
BRCGS Global Standard for Food Safety Issue 9
5 source controls mapped|7 target controls covered
6%
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
5 source controls mapped|11 target controls covered
6%
AS9100D - Aerospace Quality Management System
5 source controls mapped|5 target controls covered
6%
ISO/IEC 27003:2017
5 source controls mapped|5 target controls covered
6%
ISO/IEC 27006:2024
5 source controls mapped|7 target controls covered
6%
ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories
5 source controls mapped|7 target controls covered
6%
IEC 60601-1 - Medical Electrical Equipment Safety
4 source controls mapped|3 target controls covered
5%
SLSA
4 source controls mapped|1 target controls covered
5%
SIG (Shared Assessments)
4 source controls mapped|2 target controls covered
5%
Protective Security Policy Framework (PSPF) Release 2024
4 source controls mapped|2 target controls covered
5%
PTES
4 source controls mapped|1 target controls covered
5%
PAS 1192-5:2015 - Security-Minded Approach to BIM and Digital Built Environments
4 source controls mapped|2 target controls covered
5%
OWASP SAMM
4 source controls mapped|2 target controls covered
5%
OWASP MASVS
4 source controls mapped|2 target controls covered
5%
OpenSSF Scorecard
4 source controls mapped|2 target controls covered
5%
NIST SP 800-92
4 source controls mapped|2 target controls covered
5%
NIST SP 800-88
4 source controls mapped|1 target controls covered
5%
NIST SP 800-63-4
4 source controls mapped|2 target controls covered
5%
NIST SP 800-61
4 source controls mapped|2 target controls covered
5%
NIST SP 800-146
4 source controls mapped|2 target controls covered
5%
NIST SP 800-145
4 source controls mapped|2 target controls covered
5%
NIST SP 800-144
4 source controls mapped|2 target controls covered
5%
NIST SP 800-137
4 source controls mapped|1 target controls covered
5%
NIST SP 800-123
4 source controls mapped|1 target controls covered
5%
NIST SP 800-115 (Technical Guide to Information Security Testing and Assessment)
4 source controls mapped|2 target controls covered
5%
NIS2 Directive
4 source controls mapped|4 target controls covered
5%
MTCS (Singapore)
4 source controls mapped|3 target controls covered
5%
MITRE D3FEND
4 source controls mapped|2 target controls covered
5%
MITRE ATT&CK
4 source controls mapped|2 target controls covered
5%
ISMAP (Japan)
4 source controls mapped|2 target controls covered
5%
IEEE 1686
4 source controls mapped|4 target controls covered
5%
Azure Security Benchmark
4 source controls mapped|2 target controls covered
5%
API 1164
4 source controls mapped|4 target controls covered
5%
ISO/IEC 27010:2015
4 source controls mapped|2 target controls covered
5%
AWS Well-Architected Security Pillar
4 source controls mapped|2 target controls covered
5%
ISO 27043
4 source controls mapped|2 target controls covered
5%
IEC 62443
4 source controls mapped|4 target controls covered
5%
ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3)
4 source controls mapped|2 target controls covered
5%
ISO/SAE 21434
4 source controls mapped|2 target controls covered
5%
NIST SP 800-53 Rev 5
4 source controls mapped|4 target controls covered
5%
ISO 27019
4 source controls mapped|4 target controls covered
5%
NIST SP 1800-32
4 source controls mapped|4 target controls covered
5%
ISO 27018
4 source controls mapped|2 target controls covered
5%
NIST SP 800-190
4 source controls mapped|2 target controls covered
5%
ISO 27017
4 source controls mapped|2 target controls covered
5%
ICH E6(R3) - Good Clinical Practice
4 source controls mapped|2 target controls covered
5%
GS1 Global Standards - Supply Chain Traceability and Data Security
4 source controls mapped|3 target controls covered
5%
GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6
4 source controls mapped|2 target controls covered
5%
AS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence
4 source controls mapped|3 target controls covered
5%
IEC 62304:2015 Medical Device Software Lifecycle Processes
4 source controls mapped|4 target controls covered
5%
ISO/IEC 25012:2008 - Data Quality Model
4 source controls mapped|3 target controls covered
5%
UK AI Regulation Framework
3 source controls mapped|1 target controls covered
4%
Oman National Cybersecurity Framework
3 source controls mapped|1 target controls covered
4%
OECD AI Principles
3 source controls mapped|1 target controls covered
4%
NAIC Insurance Data Security Model Law (MDL-668)
3 source controls mapped|1 target controls covered
4%
Japan AI Guidelines
3 source controls mapped|1 target controls covered
4%
IEEE 7000
3 source controls mapped|1 target controls covered
4%
Ghana Cybersecurity Act
3 source controls mapped|1 target controls covered
4%
FISMA
3 source controls mapped|1 target controls covered
4%
BSI IT-Grundschutz
3 source controls mapped|1 target controls covered
4%
NSA Guidance for Transition to Quantum-Resistant Cryptography
3 source controls mapped|1 target controls covered
4%
FSSC 22000 - Food Safety System Certification
3 source controls mapped|1 target controls covered
4%
ISO 27005
3 source controls mapped|1 target controls covered
4%
ISO 13485
3 source controls mapped|1 target controls covered
4%
UK Gambling Commission - Cyber Resilience Requirements
2 source controls mapped|2 target controls covered
3%
OWASP DevSecOps Maturity Model (DSOMM)
2 source controls mapped|4 target controls covered
3%
NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security
2 source controls mapped|3 target controls covered
3%
ICH Q10 - Pharmaceutical Quality System
2 source controls mapped|3 target controls covered
3%
IATF 16949:2016 - Quality Management System for Automotive Production
2 source controls mapped|3 target controls covered
3%
IAEA Nuclear Security Series - Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
2 source controls mapped|3 target controls covered
3%
GAMP 5 - Good Automated Manufacturing Practice
2 source controls mapped|3 target controls covered
3%
French Sapin II Law (Law No. 2016-1691)
2 source controls mapped|2 target controls covered
3%
FedRAMP Rev 5
2 source controls mapped|3 target controls covered
3%
ISO/IEC 27011:2024
2 source controls mapped|4 target controls covered
3%
Automotive SPICE (ASPICE) v4.0 - Process Assessment Model
2 source controls mapped|3 target controls covered
3%
Annex 11 to EU GMP - Computerised Systems
2 source controls mapped|3 target controls covered
3%
NIST Cybersecurity Framework 2.0
2 source controls mapped|5 target controls covered
3%
ISO 20400:2017 - Sustainable Procurement
2 source controls mapped|5 target controls covered
3%
NIST SP 800-124 Revision 2 - Guidelines for Managing the Security of Mobile Devices
2 source controls mapped|4 target controls covered
3%
ISO 28001:2007 Supply Chain Security Management
2 source controls mapped|3 target controls covered
3%
ISO/IEC 23894:2023
2 source controls mapped|4 target controls covered
3%
NIST AI Risk Management Framework (AI RMF 1.0)
2 source controls mapped|3 target controls covered
3%
ISO 41001:2018 - Facility Management Systems
2 source controls mapped|5 target controls covered
3%
ISO 39001:2012 - Road Traffic Safety Management
2 source controls mapped|5 target controls covered
3%
ISO 22313:2020 - Guidance on Business Continuity Management Systems
2 source controls mapped|5 target controls covered
3%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
2 source controls mapped|2 target controls covered
3%
OWASP Top 10 for LLM Applications 2025
1 source controls mapped|1 target controls covered
1%
UK FCA/PRA Operational Resilience Framework
1 source controls mapped|1 target controls covered
1%
TISAX - Trusted Information Security Assessment Exchange
1 source controls mapped|1 target controls covered
1%
SA8000:2014 - Social Accountability Standard
1 source controls mapped|1 target controls covered
1%
SASB Standards
1 source controls mapped|1 target controls covered
1%
OECD Guidelines for Multinational Enterprises on Responsible Business Conduct (2023 Update)
1 source controls mapped|1 target controls covered
1%
NIST Privacy Framework
1 source controls mapped|1 target controls covered
1%
NERC CIP
1 source controls mapped|1 target controls covered
1%
Modern Slavery Act 2018 (Australia)
1 source controls mapped|2 target controls covered
1%
IRM Enterprise Risk Management Framework (Institute of Risk Management)
1 source controls mapped|1 target controls covered
1%
ICAO Annex 17 - Aviation Security (AVSEC)
1 source controls mapped|1 target controls covered
1%
German Supply Chain Due Diligence Act (LkSG)
1 source controls mapped|2 target controls covered
1%
Authorised Economic Operator (AEO) Programmes - Global Standards
1 source controls mapped|3 target controls covered
1%
APRA CPS 230 Operational Risk Management
1 source controls mapped|2 target controls covered
1%
BREEAM - Building Research Establishment Environmental Assessment Method
1 source controls mapped|1 target controls covered
1%
ISO 22316
1 source controls mapped|1 target controls covered
1%
ISO 26000:2010
1 source controls mapped|1 target controls covered
1%
ISO 22317
1 source controls mapped|1 target controls covered
1%
FBI CJIS Security Policy
1 source controls mapped|1 target controls covered
1%
ISO 22318
1 source controls mapped|1 target controls covered
1%
Space ISAC (Information Sharing and Analysis Center) - Threat Framework
1 source controls mapped|1 target controls covered
1%
ISO/IEC 29100:2024
1 source controls mapped|3 target controls covered
1%
WCAG 2.2
1 source controls mapped|1 target controls covered
1%
W3C Verifiable Credentials (VC) Data Model 2.0
1 source controls mapped|1 target controls covered
1%
UK GDPR (UK General Data Protection Regulation)
1 source controls mapped|1 target controls covered
1%
Regional Comprehensive Economic Partnership (RCEP) - E-Commerce Chapter
1 source controls mapped|1 target controls covered
1%
UK Bribery Act 2010
1 source controls mapped|1 target controls covered
1%
Trinidad and Tobago Data Protection Act 2011
1 source controls mapped|3 target controls covered
1%
Tanzania Personal Data Protection Act (Draft)
1 source controls mapped|2 target controls covered
1%
Regulation on the European Health Data Space (EHDS)
1 source controls mapped|1 target controls covered
1%
PSD2 SCA
1 source controls mapped|1 target controls covered
1%
Philippines Cybercrime Prevention Act (RA 10175)
1 source controls mapped|1 target controls covered
1%
Pakistan Personal Data Protection Bill 2023
1 source controls mapped|2 target controls covered
1%
OWASP Top 10:2025
1 source controls mapped|1 target controls covered
1%
OSFI B-13
1 source controls mapped|1 target controls covered
1%
Open Banking Security
1 source controls mapped|1 target controls covered
1%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
1 source controls mapped|1 target controls covered
1%
O-RAN WG11 Security Specification
1 source controls mapped|3 target controls covered
1%
NRC 10 CFR 73.54 - Nuclear Facility Cybersecurity
1 source controls mapped|2 target controls covered
1%
Notifiable Data Breaches Scheme (Australia)
1 source controls mapped|1 target controls covered
1%
NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems
1 source controls mapped|2 target controls covered
1%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
1 source controls mapped|1 target controls covered
1%
Nigeria Data Protection Act 2023 (NDPA)
1 source controls mapped|3 target controls covered
1%
Nebraska Data Privacy Act
1 source controls mapped|3 target controls covered
1%
NATO STANAG 4774 (Confidentiality Metadata Labels) and STANAG 4778 (Metadata Binding)
1 source controls mapped|2 target controls covered
1%
Monetary Authority of Singapore Technology Risk Management Guidelines
1 source controls mapped|1 target controls covered
1%
South Korea PIPA
1 source controls mapped|1 target controls covered
1%
ITU Radio Regulations and Space Security Standards
1 source controls mapped|1 target controls covered
1%
ITAR - International Traffic in Arms Regulations
1 source controls mapped|1 target controls covered
1%
Israel Protection of Privacy Law (5741-1981)
1 source controls mapped|2 target controls covered
1%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)
1 source controls mapped|1 target controls covered
1%
IATA Operational Safety Audit (IOSA) Standards Manual
1 source controls mapped|1 target controls covered
1%
HKMA SPM
1 source controls mapped|1 target controls covered
1%
HKMA Cyber Resilience Assessment Framework (C-RAF)
1 source controls mapped|1 target controls covered
1%
GLI-33 - Gaming Laboratories International Event Wagering Systems
1 source controls mapped|1 target controls covered
1%
GLBA
1 source controls mapped|1 target controls covered
1%
FTC GLBA Safeguards Rule (16 CFR Part 314)
1 source controls mapped|1 target controls covered
1%
Florida Digital Bill of Rights (FDBR)
1 source controls mapped|1 target controls covered
1%
FATF Recommendation 16 - Virtual Asset Travel Rule
1 source controls mapped|1 target controls covered
1%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
1 source controls mapped|2 target controls covered
1%
ISO 19011
1 source controls mapped|2 target controls covered
1%
ISO 31000:2018
1 source controls mapped|1 target controls covered
1%
ISO/IEC 30111:2019
1 source controls mapped|3 target controls covered
1%
ISO/IEC 29147:2018
1 source controls mapped|3 target controls covered
1%
ISO/IEC 27557:2022 - Organisational Privacy Risk Management
1 source controls mapped|4 target controls covered
1%
ISO/IEC 23837 - Security Requirements for Quantum Key Distribution
1 source controls mapped|3 target controls covered
1%
Illinois Biometric Information Privacy Act (BIPA)
1 source controls mapped|3 target controls covered
1%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
1 source controls mapped|1 target controls covered
1%
ISO/IEC 29134:2023
1 source controls mapped|3 target controls covered
1%
ISO/IEC 27014:2020
1 source controls mapped|3 target controls covered
1%
FedRAMP High
1 source controls mapped|1 target controls covered
1%
NIST SP 800-53 Revision 5.1 HIGH
1 source controls mapped|1 target controls covered
1%
FedRAMP Moderate
1 source controls mapped|1 target controls covered
1%
NIST SP 800-53 Rev 5 MODERATE
1 source controls mapped|1 target controls covered
1%
NIST SP 800-53 Rev 5 LOW
1 source controls mapped|1 target controls covered
1%
Barbados Data Protection Act 2019
1 source controls mapped|1 target controls covered
1%
ISO/IEC 38500:2024 - Governance of IT
1 source controls mapped|3 target controls covered
1%
ISO/IEC 27400:2022
1 source controls mapped|3 target controls covered
1%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
1 source controls mapped|2 target controls covered
1%
ISO/IEC 27031:2011
1 source controls mapped|1 target controls covered
1%
ISO/IEC 27007:2020
1 source controls mapped|1 target controls covered
1%
Azerbaijan Law on Personal Data (2010)
1 source controls mapped|1 target controls covered
1%
IEC 62351 - Power Systems Communication Security
1 source controls mapped|1 target controls covered
1%
ISO/IEC 27004:2016
1 source controls mapped|3 target controls covered
1%
ISO/IEC 27050 - Electronic Discovery (Parts 1-4)
1 source controls mapped|1 target controls covered
1%
ASIS SPC.1-2009 - Organizational Resilience Standard
1 source controls mapped|1 target controls covered
1%
ISO/IEC 29115:2023 - Entity Authentication Assurance Framework
1 source controls mapped|1 target controls covered
1%
DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)
1 source controls mapped|3 target controls covered
1%
ISO 22320:2018
1 source controls mapped|3 target controls covered
1%
ISO 19650 - Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
1 source controls mapped|3 target controls covered
1%
ISO 56002
1 source controls mapped|4 target controls covered
1%
FFIEC IT Examination Handbook
1 source controls mapped|1 target controls covered
1%
AICPA Privacy Management Framework (PMF)
1 source controls mapped|2 target controls covered
1%
IAIS Insurance Core Principles (ICPs)
1 source controls mapped|1 target controls covered
1%
ISO 37002:2021 - Whistleblowing Management Systems
1 source controls mapped|3 target controls covered
1%
ISO 37000:2021 - Governance of Organizations
1 source controls mapped|3 target controls covered
1%
ISO 26262:2018 - Functional Safety for Road Vehicles
1 source controls mapped|1 target controls covered
1%
SANS Incident Handler's Handbook and PICERL Methodology
1 source controls mapped|2 target controls covered
1%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
1 source controls mapped|1 target controls covered
1%
APRA CPS 234
1 source controls mapped|1 target controls covered
1%
ISO 22739:2024 - Blockchain and Distributed Ledger Technologies Vocabulary
1 source controls mapped|3 target controls covered
1%
COBIT 2019
1 source controls mapped|1 target controls covered
1%
PCI SSF
1 source controls mapped|1 target controls covered
1%
SSAE 18 - Attestation Standards (SOC Reporting)
1 source controls mapped|2 target controls covered
1%
SOC 2
1 source controls mapped|2 target controls covered
1%
PCI P2PE
1 source controls mapped|1 target controls covered
1%
ISO 8000 - Data Quality
1 source controls mapped|2 target controls covered
1%
PCI PIN Security
1 source controls mapped|1 target controls covered
1%
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 21 domains and 78 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 78 controls organised across 21 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 198 other compliance frameworks. The top mapping partners are 21 CFR Part 58 - Good Laboratory Practice (GLP) (21% coverage), FDA Quality Management System Regulation (QMSR) (10% coverage), PIC/S Guide to Good Manufacturing Practice for Medicinal Products (6% 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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