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

25.09.2023

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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