QP Certification for the EU and Rest of the World.

It’s almost seven years since the new revision of Annex 16 of the EU GMP Guide: Certification by a Qualified Person and Batch Release, came into effect on 15th April 2016. It was introduced due to the increased complexity of global supply chains as it was felt that the previous guidelines, relating to batches manufactured either partly or fully outside the EU/EEA had become open to interpretation.  The revision of Annex 16 in 2016 sought to address this..

2702, 2024

Vendor Requalification

February 27th, 2024|0 Comments

In any compliant quality system the initial qualification of a vendor represents only the initial step in the

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