GLP and GMP requirements both fall under the Good Practices set of requirements that govern the entire life science industry. Be it food manufacturing or drug development, all life science industries need to follow GLP GMP requirements. Right from the initial designing process to testing, manufacturing, and even distribution- every step along the way has to be performed after following some GxP standards.
However, GLP GMP requirements are indeed confusing. So, what are these? GLP stands for Good Laboratory Practices standards, and GMP stands for Good Manufacturing Practices standards. Yes, both of these are necessary for the manufacturing process of pharmaceuticals. But as is obvious from the name itself, these are concerned with very different stages of the production process.
It’s not just about the chronology of the production process though. The lab personnel who are executing these production procedures need to play different roles under GMP and GLP standards. Long story short, quality control at different stages requires different sets of standards.
So, why are the differences between GLP GMP requirements so crucial? Because confusing these two can lead to extremely dire consequences- like your product getting pulled from the market by the FDA or even a lawsuit. Go on reading if you want to avoid these unfortunate outcomes.
GMP vs. GLP
The first thing you must remember is that GLP GMP requirements may vary from one industry to the other. Also, the requirements are different for each stage of the manufacturing process. Why are these quality assurance protocols so necessary? Because the entire process of drug development needs to be standardized so that the results obtained are replicable. Unless the manufacturing process is monitored throughout, each manufacturing process would lead to different results.
Good Laboratory Practices, as the very name suggests, is concerned with the quality assurance of the processes carried out in the laboratory setting. So, of course, these are more study and research-focused. On the other hand, Good Manufacturing Practices are more production focused and concerned with the latter stages of manufacturing a product. But that’s not where the list of differences ends.
What is GLP?
Conditions maintained during an experiment, the quality of the equipment used, and the processes carried out during testing- all of these are monitored by the GLP compliance standards. Not just this, documentation and archiving are also follow-up processes that need to follow GLP requirements. Thus, it is important to track every bit of data to produce replicable results. This might not seem directly related to the market, but GLP requirements are still crucial to assure the quality control government bodies that the lab procedures have been up to the mark.
GLP requirements were first set down by the FDA in the 1970s to monitor lab safety procedures in nonclinical studies. GLP is valid for both in vitro and ex vivo systems. GLPs ensure the transparency of the lab studies so that the data can be easily verified by an external authority. Also, the intense documentation that is needed prevents the loss of any crucial scientific data.
Whether you are developing and selling drugs for humans or animals, creating food colors, medical devices, perfumes, or pesticides, you need to follow GLPs. But remember, GLP is only valid for nonclinical studies. GCP or Good Clinical Practice guidelines are applicable for clinical studies.
What is GMP?
GMPs or Good Manufacturing Practices standards were also established by the FDA but way earlier than GLP. FDA came up with GMP requirements in 1938. This should give you an idea of which set of requirements is more fundamentally needed. GMP requirements are not concerned with the laboratory, but rather the market. Any local regulatory body can have its own set of standards for the products being released in its jurisdiction. You might also be familiar with the term “cGMP”. This just means “current” GMP guidelines under which the manufacturing process should occur. Everything from plumbing, storage, hygiene, equipment maintenance, lighting, etc. is covered under these GMP guidelines.
When and Where are GLP GMP Requirements Valid?
Drug development tests often involve biocompatibility, pharmacology, and toxicology tests. All of these processes need to follow GLP guidelines. Whether the nonclinical study is being performed on microorganisms, plants, or even live organisms, to ensure the safety of everyone involved, GLP standards need to be followed.
However, do remember that basic research, discovery, screening, etc., do not require GLP standards. This is because, in these processes, there is no need to assess the safety of the samples involved. When the microbiological or chemical quality is tested, GLP requirements are not valid.
GMP, as stated before, becomes important during lot/batch release or the marketing phase. However, do remember that clinical trials often require various components that need to be tested separately. These testing processes also fall under GMP compliance standards. Process validation, stability testing, and other support activities require GMP guidelines as well.
There are some exceptions here though. Medical devices needed in clinical trials do not need to follow GMP guidelines. However, the design control testing of these devices is governed by GMP. Some biologics that are required in clinical trials and investigational drugs also don’t need to comply with GMPs.
Now that you have an in-depth understanding of what these GLP GMP requirements are, you must also understand when you need to follow these. Don’t make the very common mistake of believing that simply following GLP requirements is going to ensure that the result obtained from the experiment is correct. Think of the laboratory setting as your kitchen. You might ensure that you are following all the instructions correctly and that your equipment is high functioning. But that still doesn’t ensure the same result as the one promised in the recipe book. However, following the instructions to the tee will help you achieve a result that very nearly replicates the original design.
Just remember, the failure to follow GLP requirements can make the FDA lose faith in your testing procedures. However, the failure to follow GMP requirements can land you in hot water with the law itself. Entire batches of products are pulled from the market when the FDA discovers that GMP guidelines have not been followed. So, do be aware of the differences between both and follow whichever one is required at the moment in your domain.