No matter what type of audit you are involved in it is essential that it starts and finishes well. Opening and closing meetings offer the forum to do this. A well run and professional opening meeting sets the scene for the audit and, if done well, creates a great first impression. Likewise, a well-run closing meeting draws the audit to a close in a professional and controlled manner. TIP – if you are being audited, see how many of these points the auditor covers!
Items to cover in an opening meeting.
(Typically, this would last about 15 minutes maximum)
- Introduce the audit team and their roles.
- Allow auditees to introduce themselves.
- Remind the auditees of the reason and scope for the audit.
- Confirm that the programme is still OK.
- Clarify the role of any Guides.
- Confirm communication channels on how the audit will be run and reported.
- Confirm that any logistical requirements are OK.
- Check that any documents that you may have seen during preparation are still valid.
- Remind the auditees that the audit is to look for compliance, to add-value and promote improvements.
- Explain how audit findings will be reported during the audit and at the Closing Meeting
- Explain how any Non-Conformities (should they be seen) will be reported
- Remind the auditees that the audit is confidential.
- Explain that an audit will only look at a sample of the Quality Management System (QMS) and not the whole of the QMS.
- Check arrangements for the Closing Meeting (time, location, attendees).
- Give the auditees an opportunity to ask questions.
Items to cover in a closing meeting.
(Typically this would last 15 – 30 minutes, depending on findings)
- Record attendees.
- Give an expression of thanks.
- Remind them of the reason and scope for the audit.
- Explain how the audit findings will be reported now and in the future.
- Tell the auditees when they will get the report.
- Remind the auditees that the audit is confidential.
- Remind the auditees that an audit has only looked at a sample of the Quality Management System (QMS).
- Present your findings – use strengths to promote improvements.
- Explain any Non-Conformities (these should be against a clause of the standard being audited against).
- Provide a summary/ overview of the whole audit.
- Give any statement of recommendation (if you are permitted to do so).
- Invite discussions.
- Agree timelines for any Corrective Actions.
- Draw the meeting to a close.
Remember to include both of these meetings in your audit schedule. Keep the timings tight, as they do eat into the time allocated for your audit. Good luck with your auditing.
Please feel free to comment. For details of our courses in this area select this link: QMS Courses
THIS ARTICLE WAS FIRST PUBLISHED IN 2012 AND MOST RECENTLY UPDATED IN SEPTEMBER 2022.
Annex 1 has finally arrived, 25th Aug 2022 saw the publication of Annex 1. Normally, updates to GMP chapters and Annexes have a 6-month lead time for implementation. In the case of the new Annex 1, the lead time is 12 months, except for clause 8.123 relating to lyophilization which has 24 months lead time.
Annex 1 was first issued in 1971 as the only annex in the first ever UK guide to Good Manufacturing Practice. Since then, there have been several updates but not full revisions. In 2012 there was a proposal to revise Annex 1 with a re-proposal in 2014 by the UK’s MHRA. At the time, a full rewrite was considered unlikely and instead the intention was to provide a document that would confirm regulatory expectation and as such, not place any new requirements or costs on the pharmaceutical industry.
While this principle, is still upheld, it was clear from the first draft for public comment of December 2017, that a rewrite was being undertaken. The first draft created around 6200 comments coming from regulatory organizations, such as the pharmaceutical cooperation scheme, regulatory bodies outside of the EU, support organizations such as the Parenteral Drug Association, the Parenteral and Healthcare Sciences Society, the Pharmaceutical Microbiology Interest group as well as representatives from the manufacturers within the pharmaceutical industry to name just a few. Rarely do updates require a second public consultation but in the case of the annex 1 update a second draft was issued in March 2020 although this was a more targeted review in terms of the sections and clauses that comment was being sought for.
About the author
Andy Martin
Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew. Following this he had a number of roles culminating when he took over as QA Microbiology Manager. In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions. Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.
Training courses on Annex 1
There are a number of half-day workshops organised to take you through the changes in more detail and to look at how they relate to your organisation.
Our 2-day course is updated for Annex 1 changes
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Thank you very much for this. Very helpful!
I am completing Auditors training at the moment, Found the Opening & Closing of meeting guides very useful, will be keeping as a template