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Many auditors audit by going into areas, finding things that they don’t like and then announcing their non-conformities at a closing meeting at the end of the audit.  This is somewhat of an old-fashioned way of auditing and whilst it may be the way audits have traditionally been done it is certainly not the best way of auditing by modern standards.

During our auditor training courses we cover, amongst other things, the importance of doing the above correctly.

Raising non-conformities

These must be highlighted at the time and not saved up for the closing meeting.  The importance of raising non-conformities at the time that they are discovered cannot be emphasised enough.  The reasons for this include:

  • You are at the actual place where the issue occurred.
  • Usually all of the right people, equipment, procedures and records are there as well.
  • It helps ensures that you are actually correct and have fully understood the situation.
  • It gives the people being audited (auditees) an appreciation of how the audit is going.

Saving non-conformities up until the end of the audit and then announcing them for the first time at the closing meeting often results in difficult and confrontational meetings.  Better to have a closing meeting when you are confirming any non-conformities that were agreed during the audit itself.

Raising non-conformities against the standard

Non-conformities must be raised against the specific clause of the standard that you are auditing against.  For many people reading this article the standard will be GMP.  A related blog article  lists commonly found non-conformities linked to clauses of EU GMP.

Categorising non-conformities

It is very common to categorise non-conformities based on their severity.  There is no official standard that states what a Major Non-Conformity is.  In the first instance auditors should consult their own internal company procedures and policies to see if they already have something internally covering non-conformity classifications.

The following are general examples of what I have seen when working with a number of pharmaceutical companies:

CRITICAL – a significant risk that the end-user of the product will be harmed or killed OR a large number of related MAJORS.

MAJOR – absence of a specific requirement of the standard (such as no training, no calibration, no protection of product) OR a potential to harm or kill the end-user OR not following the requirement of the manufacturing/ marketing authorisation OR a large number of related MINORS.

MINOR – isolated lapses in following own company’s or GMP’s requirements.  No significant risk evident.

OBSERVATION – a concern that is not supported by firm evidence that something is wrong.

OPPORTUNITY FOR IMPROVEMENT – a way of spreading best practice (as auditors seek to add-value rather than just find faults).

Critical, major and minor non-conformities must be linked to clauses of the standard and must be dealt with after the audit via corrective action.

Give praise and complement where appropriate

Finally, don’t forget that the role of the auditor is not to find as many faults as you can.  Non-conformities will inevitably be raised during audits, but don’t forget to give praise and positive feedback when you see it.  Don’t worry if you don’t find any non-conformities – it is possible that a site or department is very good and are exceeding expectations.

I hope you find this post useful, as usual feel free to comment below.  If you would like any help and support with auditor training and development please get in touch.

THIS ARTICLE WAS REVIEWED AND UPDATED IN JANUARY 2023.

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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