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Validation Summary Report

Can any one let me know what exactly should be put into the validation summary report.
Does a summary report have to be given separately for IQ, OQ PQ or do we give it in the same report.

Sometimes there are deviations identified during valdiation, so is the validation summary report to be given after the deviations are verfied or before the deviations are verified.

[quote=phani]Can any one let me know what exactly should be put into the validation summary report.
Does a summary report have to be given separately for IQ, OQ PQ or do we give it in the same report.[/quote]

Common practice is that we have summary reports for IQ, OQ, and PQ’s and then an overall validation summary report that lists what has been completed successfully. The IQ, OQ PQ summary reports may contain the following headings:

  1. Purpose
  2. Scope
  3. Applicable documents
  4. Definitions
  5. General observations
  6. Deviations from acceptance criteria
  7. Deviations from protocol
  8. List of resolutions performed

[quote=phani]
Sometimes there are deviations identified during valdiation, so is the validation summary report to be given after the deviations are verfied or before the deviations are verified.[/quote]

After

[quote=phani]Can any one let me know what exactly should be put into the validation summary report.
Does a summary report have to be given separately for IQ, OQ PQ or do we give it in the same report.

Sometimes there are deviations identified during valdiation, so is the validation summary report to be given after the deviations are verfied or before the deviations are verified.[/quote]
I think an important thing to keep in the mind is that at the end of the day there is no EXACT requirement for what goes into a Validation Summary Report. To me a validation summary report is always a reflection of how a company perceives business and compliance risks and how tasks are resourced at that company.

In general, I would say the more effort one puts into the summary report the easier the validation will be to use at a later time within your company or in an audit. Nothing is better than having an auditor read a summary report and be fully satisfied. In the same context nothing is better than being able to give a coworker the exact information they need straight from a good summary report. Of course each moment invested into that report is time that could be spent on the next project.

FWIW - I have worked at companies where 1 paragraph is written as a report with a conclusion and signoff and I have worked at companies where every single table in a protocol is summarized in a report. I have seen each employed with relative degress of success/failure.

I think Mr. O’Keeffe provides a list that represents about the happy medium for industry and would be a good starting point. For formality I would include the implied Signoff/Agreement to the results. I also always encourage a comment being added as to what signoff means. Does this indicate conclusion of a project? Handoff back to production? Agreement to release product? Agreement to move from IQ to OQ?

In direct response to the item about deviations. I would expect to see a summary report to issued following the correction/justification of any deviations. In my opinion if any actions are outstanding they need to be included in a robust system that will track outstanding actions. It is not enough to “promise” to complete an action at a later time. While 99.9% of the time these promises are made with the best of intentions - Other project work captures our fancy and they fade away without a robust tracking system.

Cheers

Cover Sheet
Table of contents
Reference documentation
Purpose
Scope
Results of execution
Deviations noted
Known Issues and Special Instructions
Recommendations for release