Do QC labs work to GLP?

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. 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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4 Comments

Dominic Parry on March 30, 2012 at 2:23 pm

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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.

Dominic Parry on March 30, 2012 at 2:24 pm

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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

Dominic Parry on April 2, 2012 at 6:02 am

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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

Hani Abdeltawab on September 21, 2022 at 9:34 pm

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.

Let us know what you think Cancel reply

Dominic Parry on March 30, 2012 at 2:23 pm
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.
Dominic Parry on March 30, 2012 at 2:24 pm
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
Dominic Parry on April 2, 2012 at 6:02 am
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
Hani Abdeltawab on September 21, 2022 at 9:34 pm
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.