Kinapse welcomes you to ICH Q12

The key milestone is reached with adoption (Step 4 of ICH process) of ICH Q12 Guideline on the Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. On 4th December, ICH published final Q12 guideline and its Annex documents on the website, the next stage will be the implementation of ICH Q12 across the ICH regions.

Effective implementation of tools as outlined in the finalized guideline should enhance product knowledge and Industry’s ability to manage many CMC changes effectively under the company’s Pharmaceutical Quality System (PQS) without the requirement for extensive regulatory assessment prior to implementation.

Use the button below to download the PDFs and watch this space for support and guidance from the Kinapse team in 2020.

ICH Q12 Guidelines
ICH Q12 Annexes