ICH
has issued the following document: “Questions and Answers: Good Manufacturing
Practice Guide for Active Pharmaceutical Ingredients.”
According
to ICH, the Q7 Questions & Answers on Good Manufacturing Practice Guide for
Active Pharmaceutical Ingredients reached Step 4 of the ICH Process in June
2015 and now enters the implementation period (Step 5).
Experience
gained with the implementation of the ICH Q7 Guideline since its finalisation
in 2000 shows that uncertainties related to the interpretation of some sections
exist. Technical issues with regard to GMP of APIs – also in context with new
ICH Guidelines - are addressed in this Question and Answer document in order to
harmonise expectations during inspections, to remove ambiguities and
uncertainties and also to harmonise the inspections of both small molecules and
biotech APIs.
Posted by Tim Sandle
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