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In the past few years eight of the nine chapters of EU GMP have been updated.  However, EU GMP Chapter 9 has not been updated at all.  This is strange as GMP’s stance on Quality Management System thinking has evolved a lot of the past few years, so surely the requirements for the number one mechanism that you have to evaluate this system should be updated too?  Here are my thoughts on what I would include in a future update if I was in charge.

Below the current text is in black and my new suggestions for a revision to EU GMP Chapter 9 are in blue italics.

Title:      Self-inspection

I would change this to Internal Audit.  It is what every other sector uses to describe this activity.


Self inspections should be conducted in order to monitor the implementation and compliance with Good Manufacturing Practice principles and to propose necessary corrective measures.

I would add “and to promote continual improvement” at the end of this section.

9.1 Personnel matters, premises, equipment, documentation, production, quality control, distribution of the medicinal products, arrangements for dealing with complaints and recalls, and self inspection, should be examined at intervals following a pre-arranged programme in order to verify their conformity with the principles of Quality Assurance.

Change the opening part of this clause to “All parts of the Quality Management System should be examined at intervals …”  The reason for this is to include looking at areas and processes not covered by the current list, such as management commitment, management review, Quality Assurance, Engineering, Purchasing, training, batch review and release, problems, deviations, CAPAs, and so on.  In addition add that areas to be audited should be based on their status and importance.

9.2 Self inspections should be conducted in an independent and detailed way by designated competent person(s) from the company. Independent audits by external experts may also be useful.

This is fine.

9.3 All self inspections should be recorded. Reports should contain all the observations made during the inspections and, where applicable, proposals for corrective measures.  Statements on the actions subsequently taken should also be recorded.

Add to this clause that the report should contain any non-conformities raised.  That these should be dealt with in a timely manner, with the manager of the area responsible for this.  Dates for dealing with non-conformities should be agreed.  Any action taken should get to the root-cause of the problem.

Finally – add two new clauses.

Starting with a new clause (9.4) to include:

The results of audits should be discussed at management review, with any additional resources and expertise allocated as necessary.

And also a new clause (9.5) to include:

In the event of changes or problems in a specific area then this should be considered for additional audits.

I hope that you agree with these thoughts about EU GMP Chapter 9.  Even if not included formally in GMP then you might want to think about embracing these within your own system (if not done so already).  If you need any help with auditor related training then please visit our website for details of our Internal Auditor and Lead 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.

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