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This is a commonly asked question on my training courses which is generally misunderstood.  Quality Control (QC) laboratories that are based at classic pharmaceutical manufacturing sites DO NOT work to GLP.

GLP stands for Good Laboratory Practice, and this is the system used to cover the performance of toxicological studies on an animal, done as part of medicinal product development.

Because this has the word “Laboratory” in it it is often used to describe (incorrectly) the GMP principles applicable to QC labs.  QC labs actually work to Good Quality Control Laboratory Practice (GQCLP), and this is the term used in EU GMP to describe the GMP principles for QC laboratory work.

The term is used in Chapter 6 of GMP covering Quality Control (Select the link in blue to access the 2006 version of Chapter 6). And, this article explores changes made to Chapter 6 in 2014. Because GQCLP is a bit of a mouthful as an acronym, the shorter term of GCLP (Good Control Laboratory Practice) is often used instead.

QC labs also need to work to the other relevent chapters of GMP too, such as training (Chapter 2) and documentation (Chapter 4) for example.

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THIS ARTICLE WAS ORIGINALLY PUBLISHED IN 2012. IT HAS NOW BEEN REVIEWED AND UPDATED IN JANUARY 2023

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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