ICH Q12 Product Lifecycle Management скачать в хорошем качестве

ICH Q12 Product Lifecycle Management

ICH Q12 Guideline defines the requirement for Pharmaceutical Product Lifecycle Management specifically related to Post approval CMC changes, risk based categorization for submission of CMC changes, established conditions (ECs), Critical Process Parameters (CPPs), Post Approval Change Management Protocol (PACMP), Product Lifecyle Management Document (PLCM) and Post approval commitments. Give details of which changes require prior approval before implementation and which are just notification and also the mechanism of notification to the regulatory authority. Defines the responsibilities of Manufacturing Authorization Holder (MAH) with reference to Manufacturing Authorization Application (MAA) and required changes. The guidance gives a parameter based and performance based approach for identification of ECs. Your queries: ICH Guidelines ICH Quality Guidelines ICH Q12 Product Lifecycle Management #ich #ICHQ12 #ichguidelines #pharmaceutical About the Channel: The channel provides details of pharmaceutical guidelines, important updates on pharmaceuticals and other professional topics like interview preparation, personality development etc. Contact us at: [email protected]   / proftalks1680     / 13995930   Subscribe to our channel for more informative videos:    / @proftalks1680