View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. pharma services oehler
3 December 2018

Audit Reports at the Swiss Marketing Authorisation Holders

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.

This white paper highlights what it takes to bring a drug to the Swiss market, including the marketing authorisation application MAA), preapproval and launch preparation...
NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. A weekly roundup of the latest news and analysis, sent every Friday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy


Thank you for subscribing to Pharmaceutical Technology