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.
Feel free to add comments on this post below.
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 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.
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COMMENTS ALSO RECEIVED FROM LinkedIn:
The scope of the FDA GLPs is very specific. 21 CFR Part 58.3(d) explicitly states the following:
“‘Nonclinical laboratory study’ means in vivo or in vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety. The term does not include studies utilizing human subjects or clinical studies or field trials in animals. The term does not include basic exploratory studies carried out to determine whether a test article has any potential utility or to determine physical or chemical characteristics of a test article.”
I would think the normal activity of a “QC lab” falls outside of this scope. One would have to look elsewhere for the proper regulations and guidance for how best to conduct such activity.
If one attempts to conduct other types of lab activity under the GLPs, one can find oneself handcuffed unnecessarily. The requirements under the GLP regulations are VERY cumbersome, so much so that virtually everyone objected to them when they were first introduced.
Otherwise, what Dr. Herényi said above is correct. A QC lab can act as a testing facility that conducts GLP studies if it fulfills the requirements of the regulations. The lab’s management should, however, make sure it understands the regulatory requirements THOROUGHLY and consider carefully before it agrees to undertake such work.
COMMENTS ALSO RECEIVED FROM LinkedIn:
Within normal conditions NO. But as any other things are not white or black. If the company does not have enough lab capacity it can ask for accreditation/qualification from the local health authority. And if they can fulfil the requirements they can work as GLP lab. Of course the GLP and not GLP activities must be strictly separated and documented on different ways.
Posted by Bulcsu Herényi
COMMENT ALSO RECEIVED FROM LinkedIn:
It depends what the QC lab is testing.The regulations that cover most of the QC activities are GMP, for testing of manufacturing raw materals, in-process samples and final product, to demonstrate compliance with specifications. The GLP regulations specifically cover the non-clinical testing of a product for safety, usually mostly toxicity testing in laboratory animals, but also some in vitro testing as well. A QC laboratory does not normally do this type of testing. However, the GLP regulations require that the item which is subjected to non-clinical testing for safety must be “fully characterized” and this is where the QC lab comes in. The CoA for any sample that is to be tested under GLP is usually created by QC.
Posted by Alex Kanarek
Hi Domimic,
I believe part of the confusion comes from the differences in a “non-clinical study” definition among FDA, EPA and OECD. OECD states that “Non-clinical health and environmental safety study, henceforth referred to simply as “study”, means an experiment or set of experiments in which a test item is examined under laboratory conditions or in the environment to obtain data on its properties and/or its safety, intended for submission to appropriate regulatory authorities”. Physical/chemical testing of API/product properties and in vitro release studies are all included in the scope of GLP, according to OECD.
Now the question is: what is the purpose of the study? The answer to this question will define the regulations required for the study.