Real-Time Release Testing Strategy Plan
Plan for replacing an end-product test with real-time release testing: the attribute and the evidence that in-process measurements predict it, the control strategy and diversion criteria, the quality-system elements Annex 17 requires, the release rules once approved, and the record of regulatory interaction.
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.
The plan behind an application to replace an end-product test with real-time release testing. EU GMP Annex 17 sets minimum criteria — real-time measurements that accurately predict the finished-product attribute, scientific evidence for the combination of attributes and controls, and a robust basis for release — and lists the quality-system elements the strategy must sit within. This plan records each one.
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.
EU GMP Annex 17 (Revision 1, in operation 26 December 2018) defines RTRT, its minimum criteria (3.2), the quality-system elements (3.3), the requirement to use RTRT routinely once approved and not to substitute end-product testing on failure (3.10), and the certificate-of-analysis wording (3.11). ICH Q13 (2022) describes diversion criteria for continuous manufacturing (3.1.6). RTRT is used only where authorised; the plan structure is SPEQ practitioner synthesis.
WHERE NEXT
- FILL IT INHow to Implement Real-Time Release Testing →The procedure this template records, one step at a time.
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