A newly released Q&A from ICH on its active pharmaceutical ingredient (API) GMP guideline Q7 and another Q&A being prepared on the more recently issued API development and submission guideline Q11 are intended to address issues that have surfaced in implementing the two guidelines and drive more uniform interpretation across industry and regulators worldwide.
Focusing on the GMP expectations for API manufacturing, Q7 emerged from the ICH pipeline in 2000 and was effective in establishing a harmonized foundation for the API inspection process globally.
However, the continuing problems that agencies are seeing in API production, the increasing complexity of the international pharma supply chains, and the recurrent issues and questions that have surfaced between API manufacturers, pharma users and regulators, prompted ICH to form an Q7 Implementation Working Group (IWG) in 2012 to explore what was needed to shore up and clarify the expectations provided in the guideline.
The overall acceptance and effectiveness of the guideline led the IWG to conclude that a Q&A was the best way to do so.
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