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Our 5-day Pharmaceutical GMP Auditor/Lead Auditor Course is registered with IRCA, the International Register of Certificated Auditors (IRCA Ref:PR325).  This is the world’s premier organisation for professional auditors and sets down minimum standards for auditors and auditor training courses.

Being IRCA accredited is a way of demonstrating an individual’s minimum competency in auditing.  Whilst most pharmaceutical companies do not insist that their internal and supplier auditors are IRCA accredited, most do expect their auditors, especially their supplier auditors, to have had some form of high-level training in how to perform audits professionally This is critical not only because of the importance of the job that they are performing, but also as they are acting as ambassadors for their organisation.

Planning auditOur Pharmaceutical GMP Auditor/Lead Auditor Course is one such course and is Europe’s leading and most successful IRCA registered Pharmaceutical Lead Auditor training course.  The course covers the main principles of successfully planning, assessing, reporting and following-up of audits and is specifically tailored to train pharmaceutical auditors.  The course also includes the essential skills and roles of leading a group of auditors (being a Lead Auditor).

The course covers auditing against Good Manufacturing Practice and a range of pharmaceutical supplier standards, such as Active Pharmaceutical Ingredients GMP.  In addition, as the course covers the general principles of auditing pharmaceutical quality management systems, our course is the only such course that also includes a detailed explanation of the requirements of both ICH Q10 “Pharmaceutical Quality System” and the FDA’s “Guidance for Industry – Quality Systems Approach to Pharmaceutical CGMP Regulations”.

At the end of the course there is a written examination.  This has a high pass mark of 70%.  This is coupled with on-going continuous assessment throughout the 5-days of the course.  The working days are long, usually from 8.30 am to 7.00 pm, with some (but not too much) evening work too!  This does mean that a high standard has been established for successful course delegates.  On successful completion of the course delegates can use their certificate as part of the IRCA and PQG auditor registration process.  A range of auditor grades exist depending on experience including Internal Auditor, Auditor, Lead Auditor and Principle Auditor.

Although this sounds very serious and formal, we also bring in a great deal of humour and interest to the course which, coupled with outstanding tutors, makes for a stimulating learning experience, as the reviews for this course demonstrate.

In addition to becoming an international recognised pharmaceutical auditor other benefits of IRCA registration include recognised credibility, on-going continuous professional development and potentially greater employment prospects across the globe.

If you are interested in attending our 5-day Pharmaceutical Lead Auditor course then select the link in blue in this sentance.

You can visit the IRCA web-site by clicking this link.

Please feel free to comment, especially if you are a former course delegate.


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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