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The International Conference on Harmonization finalizes Q&A document on APIs.
The International Conference on Harmonization (ICH) announced on June 19, 2015 that Q7 Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Questions and Answers has reached Step 4 of the process and now enters into Step 5, the implementation stage. The Q&A document addresses confusion regarding interpretation of the Q7 guideline and aims to harmonize expectations during inspections of both small molecules and biotech APIs.
Topics clarified in the Q&A document are varied. The following are some of the answers ICH provides:
Other topics discussed include production and in-process controls; storage and distribution; laboratory controls; validation; change control; and contract manufacturers.
The Q7 Q&A document can be found on ICH’s guideline webpage.