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Pharmaceutical Stability Studies: A Complete GMP Guide
Pharmaceutical stability studies are controlled tests that measure how a drug substance or drug product changes over time under defined storage conditions. They are the core evidence used to justify shelf life and label storage conditions. Under GMP and ICH Q1A(R2), every program needs a QA-approved protocol, at least three registration batches, defined sampling windows, stability-indicating test methods, and full traceability of every deviation. Why pharmaceutical stability studies decide your shelf life Stability is not a paperwork exercise bolted onto the end of development. It is the single body of evidence that proves a product stays within its approved quality specification from the day it is released to the day…
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FDA CMC Requirements: What Reviewers Actually Check
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