FDA培训课件：ICH Q12上市后变更管理方案.pdf

ICH Q12: Post Approval Change Management Protocol (PACMP) FDA-PQRI April 10th, 2019 LCDR Mahesh Ramanadham, Pharm.D./M.B.A., R.Ph. Senior Scientific and Policy Advisor (Acting) Office of Process and Facilities Office of Pharmaceutical Quality Disclaimer • This presentation reflects the views of the speaker and should not be construed to represent the views or policies of FDA or ICH. 2 ICH Q12 Main Document: 1. Introduction 2. Categorization of Post-Approval CMC Changes 3. Established Conditions (ECs) 4. Post-Approval Change Management Protocol (PACMP) 5. Product Lifecycle Management (PLCM) 6. Pharmaceutical Quality System (PQS) and Change Management 7. Relationship Between Regulatory Assessment and Inspection 8. Post-Approval Changes for Marketed Products 9. Glossary 10. References Appendix 1: CTD Sections That Contain ECs Appendix 2: Principles of Change Management Annex: 1. Identification of ECs for chemical and biological products 2. PACMP 3. PLCM 3 PACMP applicability to ICH Q12 • Development approaches and timelines may not always allow for further science and risk based definition of ECs and reporting categories beyond those established by regional regulation and guidance • Q12 concepts should create opportunities for broader implementation beyond new products, or one product at a time approaches 4 PACMP • A PACMP is a regulatory tool that provides predictability a