ICH Q12 - Product Life Cycle Management

Objectives

Conference presentations, case studies and open discussions will help participants learn more about the lifecycle management of pharmaceutical products and provide a forum for discussing ICH´s new guideline. Participants will thus have the opportunity to give feedback and ask questions directly to ICH´s Expert Working Group (EWG) members on how to move forward with the transition to and implementation of the lifecycle approach.

The meeting will also address topics such as:

• Identifying “Established Conditions” for Manufacture and Control
• How could Postapproval Change Management Protocols (“Global Comparability Protocols”) look like?
• Validation as part of lifecycle activity: What is the impact of ICH Q12 on analytical method and process transfer?
• What are the skills and interfaces a „Global Life Cycle Manager“ or „Global Change Manager“ needs?

Background

The ICH Q12 topic was endorsed by the ICH Steering Committee in September 2014. Now progress has been made towards developing the draft ICH Q12 Guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management:
The Step 2 a/b draft document has been published for comment since December 2017.
The new guideline has been developed to complement the existing ICH Q8 to Q11 guidelines, especially to enable full realization of more flexible regulatory approaches to post-approval CMC changes. The guideline applies to pharmaceutical drug substances (i.e., active pharmaceutical ingredients, APIs) and pharmaceutical drug products, including marketed chemical, and biotechnological/biological products. The guideline also applies to drug-device combination products („Drug-delivery products“) that meet the definition of a pharmaceutical or biotechnological/biological product.

Therefore, the Q12 draft includes chapter on Established Conditions (ECs), Post Approval Change Management Protocols (PACMPs), Product Lifecycle Management (PLCM) documents, Pharmaceutical Quality System (PQS) and Change Management, categorization of post-approval CMC changes, relationship between regulatory assessment and inspection, and the application of Q12 for currently marketed products. Furthermore, the guideline describes how ECs are identified as well as what information can be designated as supportive information that would not require a regulatory submission, if changed. Guidance is also included for managing revisions of the ECs over a product’s lifecycle.