ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 19.6-19.7: Validate processes per section 12 once batches are for commercial use, even at pilot scale, and record every change to production, specifications or test procedures during development

What does 19.6-19.7 require?

Process validation for clinical APIs is normally not appropriate where a single batch is made or process changes make replication difficult; controls, calibration and, where relevant, equipment qualification assure quality at this stage. Once batches are made for commercial use, process validation under section 12 is expected, even if the batches are pilot or small scale. Changes are expected as knowledge grows and production scales up, and each change to production, specifications or test methods should be properly recorded.