In late May, EMA issued a guidance and a template for Qualified Person (QP) declaration of the GMP compliance of API manufacturers. The template is designed to standardize the format of the declaration and reduce the number of follow up questions. The agency recommends its use to “facilitate the validation of regulatory submissions and their review.” EMA issued a draft revision of EU GMP Annex 16 on QP batch release in July 2013 (IPQ March 27, 2014 & August 4, 2013).
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