ICH Finalizes Q&A Document on Starting Materials

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 09-14-2017 14:44


The International Council for Harmonization (ICH) moved forward a questions-and-answers (Q&A) guideline to help clarify questions when selecting and justifying starting materials for drug and biologic manufacturing. ICH brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registration. Its goal is to make recommendations toward achieving greater harmonization in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration and the maintenance of such registrations.

The Q11 Implementation Working Group (IWG), established by ICH in 2014, developed a Q&A document that reached Step 2b of the ICH Process in November 2016. The formal ICH procedure is a step-wise process consisting of five steps followed for the harmonization of all new ICH topics. An Expert Working Group works to develop a draft guideline and bring it through the various steps of the procedure, which culminate in Step 5 and the implementation in the ICH regions of a harmonized guideline. Step 2b is reached when the regulatory members (such as the US Food and Drug Administration and European Medicines Agency) endorse the draft guideline. The draft guideline reached Step 5 or the implementation step in August 2017.

The scope of the Q&A document follows that of ICH Q11, Development and Manufacture of Drug Substances (Chemical Entities and Biotchnological/Biological Entities). ICH Q11 is one of 12 quality guidelines from the ICH.

Source: ICH


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