Guidance for Industry; Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
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- Title
- Guidance for Industry; Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- Posted
- Oct 11, 2006
- Comment period
- Oct 11, 2006 – ?
- Topics
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- Oct 15, 2025Comment from Jitendra PundSupportIndividual
Jitendra Pund provides specific technical recommendations for the Phase I investigation of Out-of-Specification (OOS) test results in pharmaceutical production. The commenter suggests specific protocols for evaluating contamination, systematic hypothesis testing, the use of expired solutions for investigation, and the requirements for retesting when laboratory errors are identified.
Read comment → - Dec 23, 2024Comment from Abdelhalim IbrahimOtherIndividualRead comment →
- Dec 23, 2024Comment from Abdelhalim IbrahimOtherIndividualRead comment →