PDA TR 54-4-2015 - Technical Report No. 54-4, (TR 54-4) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations: Annex 3: Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances - 2015 - PDF
Download ReportPDA TR 54-4-2015 - Technical Report No. 54-4, (TR 54-4) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations: Annex 3: Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances - 2015 - PDF