Course Description

On 1 January 2006 the EU implemented a change to Chapter 1 of the EU GMP Guide to add the requirement to produce a regular Product Quality Review. This listed numerous criteria which should form part of that review. The FDA has long required product reports to be submitted for licensed products and ICH Q7, GMP for Active Pharmaceutical Ingredients, also requires that “processes should be periodically evaluated to verify that they are still operating in a valid manner”. This pharmaceutical training course is designed to assist you and your company in producing Product Quality Reviews which meet these GMP expectations in an efficient manner that will add VALUE to your business as well as compliance to your operations.

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