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.
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ICH Guidelines
ICH Quality Guidelines
ICH Q12
Product Lifecycle Management
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[@anilkumargore807]

good job...

[@ashleyparker9143]

This is great, please do another video including the practical implementation of the guidance with a examples/case studies

[@jainsonu30]

Very well presented the lengthy guidance. We would like to see a separate presentation to include the practical implementation of the guidance with a lot of examples.

[@proftalks1680]

Thank you very much. Surely will work on the suggestion.

[@bibhishankadam4314]

Great to have an update from you in simple language and to the points
Best wishesh to your channel.

[@proftalks1680]

Thank you very much..

[@user-se1eu5bv3x]

Very informative and useful..

[@proftalks1680]

Thank you