Yes. Twice already, 2 more in June / July.
5 minors for the first site, 3 minors for the second, so hopefully 2 A grades.
Much emphasis on GMP & plant / amenities on the first day. Second day (systems audit) was intense, little time to fit it all in.
Very keen on seeing investigations into root cause on any systems dealing with non-corforming products, calibrations, analyses, etc., and also seeing corrective & preventative actions defined in all of these systems.
Having been heavily involved in the transition to the new version, I attended both audits and was very busy retrieving system documents & information while the auditor carried on with more clauses. These audits would have been very difficult, if not impossible to complete in 2 days without at least 2 people full-time with the auditor and more people drafted in as we went into different areas.
I got the feeling that the auditors were told not to give an inch, so not much leeway for systems being in transition and having an action plan. Fair enough - we have had 6 months to comply!
Good luck to all with their audits, Mark.