Pharma Stability: Insights, Guidelines, and Expertise
Out-of-Specification (OOS) results during stability studies raise critical questions for pharmaceutical companies: Was the result valid? Should the batch be rejected? Or should the study be extended to gather additional data? Making the right decision is essential not just for scientific rigor but also for regulatory compliance. This tutorial walks you through when and how…
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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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