![]() Moreover, Q12 allows flexibility for post-approval CMC (chemistry, manufacturing, controls) changes based upon the effectiveness of a company’s PQS (pharmaceutical quality system) and risked-based change management system. The FDA is encouraging use of Q12, as it is compatible with their legal framework. Q12 is focused on the commercial phase of the lifecycle of a drug substance, drug product, and drug-device combination product. This guideline includes two annexes and aims to “promote innovation and continued improvement in the pharmaceutical sector”.Ĭhange is a natural occurrence over lifecycle due to evolving knowledge, improved understanding about processes and systems, and efforts on continuous improvement. ICH (International Council for Harmonization) recently adopted () the guideline Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. The Latest on Regulations: ICH Guideline to Manage Change throughout the Commercial Lifecycle of Drugs and Combination Products – Part 1
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |