Audit Reports at the Swiss Marketing Authorisation Holders

Do Swiss marketing authorisation holders need to have audit reports? Which requirements do they have to fulfil?

Audit reports must be on hand for new submissions or for changes to the finished product or active ingredient manufacturers in order to complete the Declaration of the Responsible Person form. The crucial point here is that the audit report explicitly refers to the EU GMP guidelines as the audit standard, since the adoption of the EU GMP requirements in the PIC/s guidelines is delayed and the two standards that are binding in Switzerland do not agree at all times. (Procedure for deviations between EU und PIC/S-GMP). An independent, documented review of the audit reports is already required in some cases.

Your contact

Any questions?
I would be delighted to answer them.

Dr. Katharina Oehler
Scientific and Managing Director
T +41 44 787 70 20
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