Checklist for OOS Handling Procedures in Stability Testing
Handling Out-of-Specification (OOS) results in pharmaceutical stability testing requires a disciplined and compliant approach. Regulatory bodies like the USFDA expect companies to follow well-documented and scientifically justified procedures to investigate and resolve OOS results without compromising data integrity. This checklist outlines a step-by-step framework to guide your team through proper OOS handling. ✅ Phase I:…
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