New Guideline from ICH proposed on Lifecycle Management - Q12

Ajit Basrur


Q12 - Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

This topic was endorsed by the ICH Steering Committee in September 2014.

This new guidance is proposed to provide guidance on a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner across the product lifecycle. Adoption of this new ICH Guideline will promote innovation and continual improvement, and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments. It will allow regulators (assessors and inspectors) to better understand the firms Pharmaceutical Quality Systems (PQSs) for management of post-approval CMC changes. This new guideline is intended to complement the existing ICH Q8 to Q11 Guidelines.

Business Plan -

Concept Paper -


Hi Ajit

I'd love to have a look at the guidelines (your first link) but it leads to a password login page. Are you able post the document?

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