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

A: Audit reports must be on hand for new submissions or for changes to the finished product or active ingredient manufacturers to complete the Declaration of the Responsible Person form.

The crucial point here is that the audit report explicitly refers to the EU good manufacturing practice (GMP) guidelines as the audit standard, since the adoption of the EU GMP requirements in the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guidelines is delayed and the two standards that are binding in Switzerland do not agree at all times.

An independent documented review of the audit reports is already required in some cases.