The Qualified Person Forum 2019
The QP is responsible for ensuring that each individual batch has been manufactured and checked in accordance with the requirements of the marketing authorisation (MA) and in compliance with GMP. This is how it is described in Annex 16 of the EU-GMP Guidelines. The Annex also describes in detail other QP’s responsibilities and activities in part 1.7.
But the QP is not responsible for everything! Most activities may be delegated and the QP can rely on the respective Pharmaceutical Quality System. How this can be done will be a central topic of this year’s QP Forum.
Don’t forget: “The ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the marketing authorisation holder (MAH).”
Make use of this event by exchanging experiences with your colleagues and by establishing informal contacts and networking. I look forward to meeting you in Munich.
Dr Ulrich Kissel
Chairman of the Qualified Person Association