PIC/S Guide to Good Manufacturing Practice for Medicinal Products
Premises and Equipment

PIC/S Guide to Good Manufacturing Practice for Medicinal Products PICSGMP-3: Chapter 3: Premises and Equipment - Design, Qualification, Calibration

Per PIC/S GMP Chapter 3: premises + equipment. Requirements include (a) implement Premises Design appropriate to operations + cleanable + minimising contamination + cross-contamination + mix-up + (b) implement Equipment Qualification including Design + Installation + Operation + Performance Qualification (DQ/IQ/OQ/PQ) per facility + (c) implement equipment calibration + maintenance + cleaning programmes + (d) maintain environmental monitoring + classification of areas + (e) implement Process Validation including initial + continued + revalidation + (f) maintain documentation of premises + equipment + qualification + maintenance.

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

What else in your programme already covers this

This control maps to 19 controls across 10 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

21 CFR Part 211 - Current Good Manufacturing Practice · 3 controls

SWIFT CSCF · 3 controls

  • SWIFTCSCF-3 Physically Secure the Environment (Objective 3)
  • SWIFTCSCF-4 Prevent Compromise of Credentials (Objective 4)
  • SWIFTCSCF-7 Plan Incident Response (Objective 7)

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

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

  • 58.49 Laboratory Operation Areas

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.

Query this from an agent

The graph holds this control, the 19 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpointAll PIC/S Guide to Good Manufacturing Practice for Medicinal Products controls