What are the responsibilities of the Qualified Person according to EU Annex 16?

15.08.2022

Question of the Week

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).

[GMP Compliance Adviser, Chapter 2.E]

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