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When people talk about good auditing technique it is easy to immediately start covering how to ask questions, how to deal with people and how to make notes.  Whilst this is all true, it is easy to forget that there are 4 stages to the audit process and good auditing technique can be used at all of these stages – as we will see.  This makes for a better audit.

The 4 stages of an audit are – PLANNING, ASSESSMENT, REPORTING and FOLLOW-UP.  The “assessment” part is the part of the audit when you are on-site.  Here are some examples of good auditing technique for each stage:

PLANNING

  • Make contact with the auditee
  • Arranging and agreeing a date and time
  • Explaining the reasons for the audit and the standard to be audited against
  • Reviewing any pertinent documents in advance of the audit
  • Production of a programme
  • Production of any checklists

ASSESSMENT

  • Asking good questions and listen to the answers
  • Asking further questions – rephrasing if necessary
  • Taking notes
  • Use “open” questions
  • Don’t make assumptions
  • Treat people as equals
  • Speak to a range of people
  • Communicate in an open and non-aggressive manner
  • Have knowledge of the standard being audited against
  • Have knowledge of the activity being audited
  • Be tactful when dealing with people
  • Provide feedback and highlight findings as you see them
  • Be decisive
  • Focus on the bigger picture rather than the trivial
  • Audit against the standard – not your opinions
  • Run good opening and closing meetings – see related post on their contents

REPORTING

  • Writing a report within agreed timescales
  • Ensuring the report captures all that was seen during the audit
  • Having an accurate report
  • Including any non-conformities seen

FOLLOW-UP

  • Ensuring that appropriate corrective actions are taken
  • Seeing objective evidence of this
  • Communication to the auditee on completeness of actions
  • Asking for further information/ action if not satisfied
  • Ensuring actions are taken within agreed timescales
  • Informing key personnel when the audit is closed
  • Closing and storing the report correctly

If you want any help with performing some of your audits or if you need any auditor training then please get in touch.

Our Internal Auditor and Pharmaceutical Lead Auditor training courses are extremely popular and highly regarded within the industry – seen as some of the best (if not the best) such courses available.  

Regards,

Dominic

info@inspiredpharma.com

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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