7 Process Validation Report Tips
If I was limited to only 12 tips for someone drafting a process validation report, these are the first 7 I would give...
Executive Summary or Purpose section
Clearly state whether the validation passed or failed
Note the number of deviations / discrepancies observed and the impact to the study of each.
Indicate the quality characteristics tested
List or reference all parts / products within the scope of the validation
Risk Management section
Note the risk associated with each quality characteristic
Acceptance Criteria section
Re-state the protocol acceptance criteria, sample size AND statistical rationale.
Results Summary section
Only provide a summary of the results in the report's main body (raw data and detailed analysis should be presented in the annex / forms / appendices / attachments)
Click on the checklist image below to get the full list of 12 tips + 1 bonus tip!
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