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New online GMP course for QA personnal now available

Following requests from several of our clients we have just released a new Chapter in our very popular GMP online course range.

The Chapter is aimed at helping QA personnel to understand their role in helping their organisation to comply with the GMP regulations.

It can be used for new starters or as part of a refresher/compliance programme.

Two versions are available – to make a purchase click on one of the links below:

GMP for QA Personnel

3 Core Chapters plus Chapter 9 as detailed above

Duration: Around 70 minutes  Cost per learner £95 plus VAT

GMP for QA Personnel – Single Chapter

Duration: Around 40 minutes  Cost per learner £45 plus VAT

Or, to find out more about our range of online courses, including the full range of our GMP courses then use the links below.

And, to try a free taster of these courses to see if they are of interest visit this page.

Expect more news going forward of new initiatives including more virtual classrooms. And if you have any ideas for us to consider, then please feel free to get in touch.

Keep safe, everyone

Best Regards

Dominic Parry 

Content covered in our 40 minute course:

Article 6 from the GMP Directive

Role of three key personnel in GMP

Independence of Head of QC and Head of Production

What does QA do?

Activities QA normally involved in:

  • Validation
  • Documentation
  • Keeping records
  • Training needs identification
  • Supplier approval
  • External Audits
  • Change Control
  • Managing deviations
  • Complaints and Customer Satisfaction
  • Investigations and Root Cause Analysis
  • CAPA’s
  • Risk Assessments
  • Internal audits
  • Batch records
  • Review of whole QMS
  • Product Quality Review
  • Management Review
  • Improvements

ICH Q9 and Q10

See the promotional video below:


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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GDP/RP Training


GMP Compliance


QP Training


GDP Compliance


Free Taster courses

To try a free taster of our online courses to see if they are of interest visit this page.