GMP: ICH announces Q&A Document on Q11 Guideline - Main Focus: API Starting Materials

The ICH Q11 Guideline entitled \"Development and Manufacture of Drug Substances\" from May 2012 has been implemented in the three ICH regions EU, USA and Japan for 2 years now. It describes the approach to developing APIs based on an in-depth understanding of the manufacturing process and adequate strategies to control this process. The document indicates what information should be provided about the quality of the API in Module 3 of the CTD (Common Technical Document) within the framework of a marketing authorisation application.

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