21 CFR Part 211 - Current Good Manufacturing Practice
Subpart G - Packaging and Labeling Control

21 CFR Part 211 - Current Good Manufacturing Practice CFR211-G-122: Section 211.122 - Materials Examination and Usage Criteria

There shall be written procedures describing the receipt, identification, storage, handling, sampling, examination, and/or testing and approval or rejection of labeling and packaging materials.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

What else in your programme already covers this

This control maps to 58 controls across 47 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

API 1164 · 1 control

  • API1164-02 Risk Management Framework

BSI IT-Grundschutz · 1 control

  • BSI-15 Security categorization
  • QMSR-820.45 Device labelling and packaging controls (§820.45)

FISMA · 1 control

  • FISMA-NIST-800-53-RMF-800-171-FIPS Operationalisation via NIST 800-53 + 800-37 RMF + 800-171 + FIPS 199 + FIPS 200
  • GhCSA-Implementation-Roadmap Implementation Roadmap - Organizational Roles, Tooling and Metrics
  • 60601-1.7.1 Equipment identification and marking

IEC 62443 · 1 control

  • IEC62443-02 System security categorization

IEEE 1686 · 1 control

  • IEEE1686-Scope-IED-Substation-Automation-2022-IEC-NERC-NIST-Coord IEEE 1686 - Scope + Intelligent Electronic Devices (IEDs) + Substation Automation + 2022 Edition + Coordination with IEC 62351 + IEC 62443 + NERC CIP + NIST SP 800-82

IEEE 7000 · 1 control

  • IEEE7000-EthicalRisk-Identification-Analysis-Treatment-ValidationOutcomes IEEE 7000 Clauses 8 + 8.1 + 8.2 - Ethical Risk Identification + Analysis + Treatment + Validation of Ethical Outcomes + AI Safety + Robustness + Adversarial Protection

ISMAP (Japan) · 1 control

  • ISO-14064-1-5.4 Categorization of indirect GHG emissions

ISO/IEC 27010:2015 · 1 control

  • 27010-8.2 Membership Termination

ISO/IEC 27019:2024 · 1 control

  • ISO27019-02 System security categorization

ISO/IEC 27043:2015 · 1 control

  • ISO27043-08 Information classification and labeling

ISO/SAE 21434 · 1 control

  • ISO21434-08 Information classification and labeling

Japan AI Guidelines · 1 control

  • JP-AIG-Risk-Based-AI-System-Categorisation-Tiered-Approach-EU-AI-Act-Aligned-Generative-Foundation-Models Japan AI Guidelines Risk-Based AI System Categorisation + Tiered Approach + EU AI Act Aligned + Generative AI + Foundation Models + High-Risk + Limited-Risk + Minimal-Risk + AISI Capability-Based Thresholds

MITRE ATT&CK · 1 control

MITRE D3FEND · 1 control

MTCS (Singapore) · 1 control

  • MTCS-Acquisition-Development-Maintenance-Supplier-Vulnerability-DevSecOps-SBOM-SDLC-SCA-API-Container MTCS Acquisition + Development + Maintenance + Supplier + Vulnerability + DevSecOps + SBOM + SDLC + SCA
  • NAIC-2 Information Security Program (ISP) - Section 4

NIST SP 1800-32 · 1 control

  • NISTSP115-8 Operational Considerations - Tools, Reporting Templates, ISMS Integration, Annex Material

NIST SP 800-123 · 1 control

NIST SP 800-137 · 1 control

  • NISTSP137-1 ISCM Strategy, Governance, and Volatility Assessment

NIST SP 800-144 · 1 control

  • NISTSP144-5 Identity and Access in Cloud, Federation, and Privileged Access

NIST SP 800-145 · 1 control

  • NISTSP145-8 Governance, Reporting, and Stakeholder Education on Cloud Definition

NIST SP 800-146 · 1 control

NIST SP 800-190 · 1 control

  • NISTSP61-4 Detection and Analysis: Sources, Triage, Categorisation, Prioritisation

NIST SP 800-63-4 · 1 control

  • NISTSP63R4-7 Privacy, Records Retention, and User-Controlled Wallets

NIST SP 800-88 · 1 control

  • NISTSP88-1 Media Sanitization Policy, Roles, and Decision Framework

NIST SP 800-92 · 1 control

  • NISTSP92-7 Privacy in Logs, Sensitive Content Handling, Cloud and SaaS Log Considerations
  • QRCM-1.3 Data Classification for Migration

OECD AI Principles · 1 control

  • OECDAI-3 Robustness, Security, Safety, and Adversarial Attack Protection

OWASP MASVS · 1 control

OWASP SAMM · 1 control

  • OWASPSAMM-2 Design: Threat Assessment, Security Requirements, Security Architecture
  • OMANCS-4 Data Protection, Cryptography, and Privacy Alignment

OpenSSF Scorecard · 1 control

  • OSSFSC-2 Dependency Management, Pinning, Updates, Vulnerability Tracking
  • PASONE-1 Security Triage Process, Asset Sensitivity Classification, and Threat Assessment

PTES · 1 control

  • PTESPHASE-1 Pre-Engagement Interactions and Scoping
  • PSPF24-2 Information Security, Cybersecurity Maturity, Essential Eight

SASB Standards · 1 control

  • SASB-SOC-7 Selling Practices and Product Labeling
  • SHAREASSESS-2 Access Control, Identity, Authentication

SLSA · 1 control

  • SUPCHAIN-1 Build Integrity - Source, Build, Provenance
  • UKAI-1 Risk-Based Approach and Pro-Innovation Principles

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Subpart G - Packaging and Labeling Control

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