Protocol · VAL-P10
Requalification and Periodic Review Procedure
Triggers, frequency and content of requalification and periodic review.
Purpose
To define when and how qualified equipment, storage areas, vehicles, shippers and monitoring systems are requalified and periodically reviewed, so that their validated state is maintained over time and after change, and so that the frequency of requalification is justified by risk and performance history.
What is inside
14 sections, about 3 pages when printed.
- 1. Purpose
- 2. Scope
- 3. Responsibilities
- 4. References
- 5. Definitions
- 6. Triggers for requalification
- 7. Requalification intervals
- 8. Periodic review
- 9. Requalification execution
- 10. Tracker
- Deviations
- Data integrity
- Report
- Approval
Before you use it
- Replace every square-bracket token, starting with [LABORATORY NAME], [ADDRESS] and [EFFECTIVE DATE]. The full token list is in GD-01 Read Me First.
- Have the content technically reviewed against how your laboratory actually works, then approved by the responsible manager before it becomes a controlled document.
- Update the Word fields after editing so the table of contents and page numbers are correct: select all, then press F9.
- Record the document in your own document register and set its review date.
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