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.
What a template is not
A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.
A plan applying a risk- and science-based verification approach, concentrating qualification effort on the aspects of a system that are critical to product quality and patient safety and leaving the rest to good engineering practice. The plan's real content is the criticality determination: which aspects are critical, on what basis, and who with the relevant subject-matter expertise approved that judgement.
What's Inside
How to Use It
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.
ASTM E2500-25 describes a risk- and science-based approach to specification, design, and verification of manufacturing systems, with subject-matter experts approving the critical-aspect determinations. The ISPE Baseline Guide Vol. 5 (2nd ed.) on Commissioning and Qualification applies that approach in practice, and EU GMP Annex 15 sets the qualification expectations the approach must satisfy. What is critical at your facility is your determination, made by your subject-matter experts and recorded here — no standard makes it for you.
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