ICH has released a new Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients on 10 June 2015. The Q&A document is intended to respond to the requests received by ICH for guidance concerning implementation of Q7. The document is 18 pages in length and the annex provides a cross-reference of the Q&A sections to the sections contained in Q7. As cautioned by ICH, it is important for individuals responsible for Q7 implementation to read the entire Q&A to ensure complete understanding of the linkages between sections, allowing the appropriate application of Good Manufacturing Practices (GMPs) at all stages of API manufacturing and distribution.
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Brad Henry
Vice President, Indiana Division Director - Brad has over 20 years of experience managing and executing CQV projects for the pharmaceutical and medical device industries. He has extensive experience in dry products, parenteral, facilities and utilities, and in-vitro diagnostics.
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