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There are key elements that should be covered when dealing with third-party auditors, according to Siegfried Schmitt, vice president, Technical, at Parexel.
Q: According to our standard operating procedure (SOP), we perform supplier audits during the selection process and as part of ongoing oversight. Although we try to perform as many of these audits ourselves, we do need to rely on third parties to manage the volume of good manufacturing practice (GMP) audits. Is there an international standard for third-party GMP audits?
A: Interestingly, there isn’t such a standard. There are a large number of articles and presentations freely available on the subject, but these may give you conflicting advice, leaving you perhaps confused. This lack of standardized approach has been realized, and a working group (VDI EE 6306, 3rd Party GMP-Audits) under the auspices of The Association of German Engineers (VDI) was formally established in 2023, with the aim of establishing precisely such a standard. That work has already progressed well, and the document is currently under review by regulators and other interested parties. Its publication in German and English is just a matter of time.
Meanwhile, you could verify that your SOP covers all the key elements relating to audits performed by your third parties, namely:
The actual standard will of course provide much more detail on each of these aspects, and it will hopefully provide you with exactly what you need.
Siegfried Schmitt is vice president, Technical, at Parexel.
Vol. 47, Number 11
When referring Schmitt, S. Using a Third Party to Perform Audits. Pharmaceutical Technology 2023 47 (11).