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A good audit report is critical

An audit report is an essential part of the audit and it’s purpose is to report what you have actually observed when on-site.  The audit report contents are therefore very important, so that there is an accurate record of what was seen.  I see a wide range of audit reports and a variety of styles adopted.  The worst form of “audit report” that I see simply lists any non-conformities that were seen.  Whilst these must be included, they are not a true audit report, as the report should be a record of what was seen during the audit, including any good points.

Audit report production

Some audit reports are produced originally as Word documents and some are produced using specialist audit software.  The latter can help ensure that all reports produced within the same organisation have the same content and structure, but on the downside they mean that important information may be omitted in a report, depending on how the source document or template has been set-up.

Audit report contents

Here is a list of things that should be included in the content of an audit report.

  • The name of the organisation, department, process or function being audited
  • The address of the site audited (for external audits)
  • The date and duration of the audit
  • The reason for performing the audit
  • The standard that was used during the audit
  • The name of the key contact for the audit (the host) and their contact details
  • The names of the auditors
  • The people at the opening meeting
  • The people at the closing meeting
  • A statement of confidentially
  • The audit programme or agenda
  • If there were any obstacles encountered
  • An overview of all areas seen during the audit, including what happens in these areas
  • Any non-conformities and observations that were raised
  • Any specific areas that were not looked at
  • A description of the meaning of any gradings of any non-conformities (for example Major or Minor)
  • The conclusions as a result of performing the audit
  • Instructions of what you want the organisation or department to do on receipt of the report. This is likely to be that they need to respond to any non-conformities raised and that you need to see evidence that effective corrective action has been taken.
  • A list of people who need to be sent the report

I hope this helps with the production of any audit reports and their content.  It is well worth including these so that the report makes sense to others in the future.  If you would like to add any thoughts or comments, then by all means do so.  Good luck with your auditing.

If you need any more detail on how to perform effective audits, then consider attending one of our highly praised auditor training courses.

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 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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