Hanging word Q&A

ICH Q7 cGMPs for APIs Q&A Guidance Issues

Today, FDA published guidance titled “Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients – Questions and Answers.”  FDA explains that, since ICH Q7 has published, there have been many questions raised by firms, both domestic and international, requesting clarification on issues raised in the ICH document.

The Q&A document referenced above responds to those questions.  There are close to 60 questions posed covering almost every section of ICH Q7.  In addition, there is an Annex linking all questions to the relevant section of the ICH document.

While much of the responses provide clarification on specific issues, the entire document also appears to reflect current FDA thinking and expectations.  In some instances, there are no real clear-cut answers, as many of the Agency questions relate to action by industry on risk-based analysis that would drive the final determination of the proper course of action.  The FDA’s Q&A document can be found here and will provide the reader some good insight into questions that have been raised by industry.