Handling of unexpected deviations
Every batch of medicinal product must be certified by a Qualified Person (QP) of the EU manufacturer or importer before being released for sale. The certifying QP takes responsibility for ensuring that each batch has been manufactured and checked in compliance with the laws in force in the Member State where certification takes place, in accordance with the requirements of the marketing authorisation (MA) and Good Manufacturing Practice (GMP).
Annex 16 to the EU Guide to GMP provides specific guidance on certification by a QP and batch release. The Annex has recently been revised, with theupdated version coming into effect from 15 April 2016.
The purpose of this post is to look in more detail at one aspect of the new Annex 16 – the handling of unexpected deviations.
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