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From Part 1 of this post we highlighted that there is no formal need for a QA Manager or Department in GMP.  EU GMP does require you to have a QA system, but there is no mention of who should manage the system.  In a number of courses that I have presented in the past we have looked at what the delegates think QA’s role should be, bearing in mind the role is not defined in GMP.  Roles already assigned in GMP to the Head of QC and the QP can be delegated to QA, with additional roles added as well. Their findings are below:

The QA Manager (suggested duties from course delegates)

  • Control of Licences
  • Liaison with Research & Development/ New Product Introduction
  • Batch Review
  • Batch Release
  • Management of the Document Management system
  • Management of the Internal Audit system
  • Management of the GMP Training System
  • Customer feedback and satisfaction
  • Management of deviations, incidents and investigations
  • Management of the Validation system
  • Vendor assurance and supplier auditing
  • Control of sub-contractors
  • Performance monitoring and review
  • Management Review
  • Management of the Continual Improvement system
  • Gathering and Trending of quality related data
  • Data storage
  • Management of the Product Quality review process
  • Management of the Risk Management process
  • Management of the Corrective Action system
  • Management of the Preventative Action system

These are roles commonly performed by QA departments.  They are opinions from former GMP training course delegates and should not be seen as a specific GMP requirement.  Please let us know what you think.  Are these similar to your own QA department?

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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