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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.

Scope section

  • 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)

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