21 CFR Part 211 - Current Good Manufacturing Practice
Subpart I - Laboratory Controls

21 CFR Part 211 - Current Good Manufacturing Practice CFR211-I-176: Section 211.176 - Penicillin Contamination

If a reasonable possibility exists that a non-penicillin drug product has been exposed to cross-contamination with penicillin, the non-penicillin drug product shall be tested for presence of penicillin.

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

What else in your programme already covers this

This control maps to 23 controls across 14 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

FDA Quality Management System Regulation (QMSR) · 2 controls

GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6 · 2 controls

  • GGAP-IFA-AllFarmBase-Mgmt-Workers-Env-Trace GLOBALG.A.P. IFA v6 All Farm Base (AF): Management, Workers, Environment, Traceability and Food Safety
  • GGAP-IFA-CropsBase-Production-PPP-IPM GLOBALG.A.P. IFA v6 Crops Base (CB): Propagation, Soil, Water, IPM, PPP, Fertilizer and Harvest

GS1 Global Standards - Supply Chain Traceability and Data Security · 2 controls

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence · 2 controls

  • ISO-15189-6.3 Facilities and environmental conditions
  • ISO-15189-6.5 Equipment calibration and metrological traceability

PCI DSS 4.0 · 2 controls

  • 2.1.1 2.1.1 Requirement 2 policies and procedures governed
  • 2.1.2 2.1.2 Requirement 2 roles and responsibilities assigned

PIC/S Guide to Good Manufacturing Practice for Medicinal Products · 2 controls

  • PICSGMP-3 Chapter 3: Premises and Equipment - Design, Qualification, Calibration
  • PICSGMP-4 Chapter 4: Documentation - System, Record-Keeping, Data Integrity

21 CFR Part 58 - Good Laboratory Practice (GLP) · 1 control

  • 58.49 Laboratory Operation Areas

FSSC 22000 - Food Safety System Certification · 1 control

  • FSSC-Additional-Requirements-v6 FSSC 22000 Additional Requirements v6 (Food Defense + Food Fraud + Allergen + Environmental + Culture)

ICH E6(R3) - Good Clinical Practice · 1 control

IEC 62304:2015 Medical Device Software Lifecycle Processes · 1 control

  • IEC62304-5.1 Software Development Planning

ISO/IEC 17025:2017 - General Requirements for Testing and Calibration · 1 control

  • ISO-17025-6.5 Metrological traceability

ISO/IEC 25012:2008 - Data Quality Model · 1 control

  • ISO-25012-4.11 Traceability

SQF Code Edition 9 - Safe Quality Food · 1 control

  • 2.1.3 Food Safety and Quality Culture

Singapore AI Governance Framework · 1 control

  • AIGF-3.3 Repeatability and Traceability

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 I - Laboratory Controls

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The graph holds this control, the 23 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpointAll 21 CFR Part 211 - Current Good Manufacturing Practice controls