Posted 11 May 2012
By Alexander Gaffney
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) announced 11 May it has finished worked on its Q11 quality drug manufacturing guideline and is preparing to notify various international regulatory bodies so they can implement the guideline.
ICH said its Q11 guideline, Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological Biological Entities, will now be sent to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other EU signatories, and Japan's Ministry of Health, Labor and Welfare (MHLW) for implementation.
Q11 "describes approaches to developing process and drug substance understanding and also provides guidance on what information should be provided" in several sections of the Common Technical Document (CTD), wrote ICH in a press release.
The guideline also "provides further clarification on the principles and concepts described in ICH Guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality Systems (Q10) as they pertain to the development and manufacture of drug substance."
Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological Biological Entities
ICH Quality Guidelines
ICH Q11 reaches Step 4 of the ICH Process