How to structure a qualification protocol
A protocol says what will be tested, how, by whom, and what result counts as a pass — all approved before execution begins.
- Title, unique identifier, version, approvals (author, reviewer, quality).
- Purpose, scope and system description.
- References: URS, DQ, drawings, procedures, standards.
- Responsibilities.
- Prerequisites: calibration status of test equipment, training, completed prior stages.
- Test procedures, each with: requirement reference, method, equipment, acceptance criterion, result field, executed by/date.
- Deviation handling and how results are recorded.
- Attachments: calibration certificates, raw data, diagrams.
The report mirrors the protocol test by test, adds the deviations and their resolution, and states whether the system is qualified — signed by the same roles that approved the protocol.
Frequently asked questions
- Can acceptance criteria be changed after execution?
- Only through a documented, justified and approved amendment — and changing a criterion to make a failed test pass is exactly what inspectors look for.
References
- [1]EudraLex Volume 4, Annex 15: Qualification and Validation (2015)
General technical guidance written against the cited sources. It is not regulatory or legal advice and does not replace the applicable standard, guideline or a qualified reviewer's judgement.
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