ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 8.2: Meet time limits set in the master instructions, document and evaluate deviations, and hold intermediates under suitable conditions

What does 8.2 require?

Where the master production instruction sets time limits, they should be met to protect the quality of intermediates and APIs, and deviations documented and evaluated. Time limits may not fit steps processed to a target value (for example pH adjustment, hydrogenation or drying to specification) where completion is decided by in-process testing. Intermediates awaiting later processing should be kept in conditions that keep them suitable for use.