Tuesday, 7 August 2018

Annex 16 Q&A – Unexpected deviation


Annex 16 Q&A – Unexpected deviation: what is the Role of the QP? With this guidance document the EMA has updated its Q&A on Annex 16 to further clarify the role of the QP in the context of handling unexpected deviations.

The new questions are:

1. Can a site have more than one QP performing certification of batches?

2. Can there be more than one QP involved in the certification of a given batch?

3. In the context of handling unexpected deviations, what is included in the scope of registered specifications for medicinal products? / What is an ‘unexpected’ deviation? / Does Annex 16 permit QP certification of more than one batch affected by the same unexpected deviation?

In Europe, the QP is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the marketing authorisation (MA) and with Good Manufacturing Practice (GMP).

Reference: EU GMP

Posted by Dr. Tim Sandle

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