1.Cross reference the FDA Process Validation Guidance of 2011. 2.Cross reference and include where possible the Annex 1. 3.Update referenced documents to include FDA guidance, Annex 1, PDA TR 60, others?
Keywordscontinuous improvement; continuous quality monitoring; continuous quality verification; process capability analysis; process control strategy; process understanding; real-time release;
Ballot Item Approved as E2537-2016 and Pending Publication