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PLANREFERENCE OUTLINE
Commissioning & Qualification (C&Q) Plan
Risk- and science-based C&Q plan concentrating qualification effort on the aspects critical to product quality and patient safety. Maps to ASTM E2500, ISPE Baseline Guide Vol. 5, and EU GMP Annex 15.
REGULATIONS MAPPED
ASTM E2500ISPE Baseline Guide Vol. 5EU GMP Annex 15
DOCUMENT TYPE
PlanLAST UPDATED
January 2025PURPOSE
A commissioning and qualification plan applying the ASTM E2500 risk- and science-based approach — focusing verification effort on the aspects of a system critical to product quality and patient safety.
What's Inside
✓System boundary and GxP criticality
✓Requirements and design review basis
✓Critical aspects and CQA linkage
✓Verification strategy (commissioning + qualification)
✓Acceptance, handover, and SME approval
How to Use It
1Define the system boundary and its criticality
2Establish the requirements and design basis
3Identify critical aspects tied to product quality
4Plan verification effort proportionate to risk
5Leverage commissioning; qualify only what’s critical
DOCUMENT CONTENTS
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Purpose, Scope, and System Boundary
2GxP Criticality Assessment
3Requirements and Design Review Basis
4Critical Aspects and CQA Linkage
5Verification Strategy and Effort
6Roles and SME Approval Model
7Acceptance and Release / Handover
8Documentation and Traceability
REGULATORY CONTEXT
ASTM E2500, the ISPE Baseline Guide Vol. 5 (C&Q), and EU GMP Annex 15 frame a risk-based verification approach. This plan concentrates qualification effort on the critical aspects rather than every attribute.