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New January 2022 date for GMP Lead Auditor

The demand for our IRCA registered Pharmaceutical GMP Auditor/Lead Auditor Course continues to grow with delegates from around the globe accessing the ‘live online interactive’ course from their workplace or home. Just in the last month, in addition to UK delegates, we have welcomed Pharma personnel from Denmark, Egypt, India, Romania and Switzerland. Our next 4 courses in December and January are already full! Therefore, we have organised a new date starting on January 24th – to book visit this page.

The ‘Traditional’ classroom returns

Our ‘live online interactive’ course format has been very successful and has attracted delegates from the UK and around the globe who can access the course from their home or their workplace . As a result, this format is set to stay as one of our prime ways to deliver our courses. However, we are aware that there are people who would much prefer the more traditional classroom course. So, from March 2022 we have scheduled some of of our more popular courses to take place at our Reading venue:

1st – 3rd March Advanced Good Manufacturing Practice

25th March  Good Distribution Practice

28th March – 1st April Pharmaceutical GMP Auditor/Lead Auditor Course

16th – 20th May Pharmaceutical GMP Auditor/Lead Auditor Course

Obviously, if it is not practical to run these courses due to COVID restrictions of some sort then we will revert to the ‘live online interactive’ format.

New versions of online GMP, GDP and Data Integrity courses now available

Our online Royal Society of Chemistry  Approved GMP, GDP and Data Integrity courses have all been recently updated. The 20-minute  Data Integrity course now includes an update for ALCOA+. The Good Manufacturing Practice and Good Distribution Practice courses now include updates to our UK version to reflect our departure from the EU, and our EU/EFTA version now reflects the current position.

I look forward to seeing you online (or perhaps in a classroom) soon. Keep safe.

Dominic Parry


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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