Do you do API?

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.