ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 19.8-19.9: Use scientifically sound methods for clinical batches, retain reserve samples and records for an appropriate period after the application ends, apply dating rules to existing APIs and document development knowledge

What does 19.8-19.9 require?

Analytical methods used to evaluate clinical batches may not yet be validated but should be scientifically sound. A system should retain reserve samples of all batches in sufficient quantity for a suitable period after the application is approved, terminated or discontinued. The expiry and retest dating rules of section 11.6 apply to established APIs used in trials, though not normally to new APIs in early trials. A system should ensure information gained in development and manufacture is documented and available, the development and implementation of release methods documented, and production and control records kept for a suitable period after the application is approved, terminated or discontinued.