All You Need to Know About GLP GMP Requirements in Pharmaceutical Industry

If you are someone who works in sectors such as food safety or drug development, you must already be aware of these terms: GLP and GMP. However, even the most seasoned personnel in these industries sometimes get these two terms mixed up. So, in this article, you will not only find all you need to know about GLP GMP requirements but the crucial differences between the two will also be clarified once and for all.

Before we get to the exact definitions of both the terms, you need to know that it is the Food and Drug Administration (FDA) that governs both of these requirements. However, this is where the list of similarities ends. Confusing the two terms can be disastrous for business because this might actually result in your product getting banned from the market.

What is GLP? And Why Does It Matter?

GLP stands for Good Laboratory Practice. This requirement is completely limited, as the name suggests, to the laboratory setting itself. Basically, there is a standard set of procedures (also known formally as Standard Operating Procedure) that needs to be put into place by qualified professional experts before the scientific study can even begin. GLP requirements state that this Standard Operating Procedure is decided and enforced by the laboratory management and administrators.

GLP requirements ensure that all the proper laboratory standards (with regards to equipment and procedures) are complied with while a certain drug is being tested. Every drug study is different and different protocols need to be followed during each process. The study director and the study sponsor are the ones who design these sets of protocols. GLP simply ensures that these different sets of protocols are followed.

To ensure compliance with GLP requirements, the signatures of all the staff members participating in the study are collected. These signatures have to be archived for a minimum of five years after the date of registration or two years after the date of testing.

What is GMP?

As you must have already guessed from the description of GLP above, GLP is valid mostly for drug development where laboratory setups are needed. However, GMP isn’t concerned with the laboratory setting at all.

GMP stands for Good Manufacturing Practices. GMP is wholly concerned with whether or not a product can be released into the market. Though FDA is the body that oversees compliance with both GLP and GMP requirements, it can be ascertained that they are more directly involved with manufacturing practices.

While non-compliance with GLP requirements simply means that the required laboratory standards haven’t been adhered to, non-compliance with GMP requirements can result in a complete product ban or even jail time.

GMP requirements are crucial for food manufacturing bodies. A strict quality control unit ensures that the required Standard Operating Procedures are followed during the manufacturing process. While in GLP, collecting the signatures of the experimenters is enough, the same is insufficient for GMP.

GMP involves two parties. The technicians who handle the manufacturing process and the quality control unit maintain vigilance. To adhere to GMP requirements, the signatures of both parties need to be collected.

Differences between GLP and GMP requirements

Though the differences between GLP and GMP requirements might be clear already, one has to consider the most obvious factor. The areas where these two are relevant are very different. While both can be required for the drug manufacturing process, GLP is concerned with areas like toxicology, pharmacology, biocompatibility, and so on.

GMP is concerned with the entire manufacturing line, from the initial sourcing of raw materials to packaging. An easy way to remember this is by associating GLP with clinical and GMP with non-clinical sectors. GMP might also be valid in clinical sectors, but it is strictly restricted to the pre-clinical and the post-clinical periods of the manufacturing process.

Long story short, GLP proves the scientific validity of an experiment process. It doesn’t ensure, at all, that the product or the inference obtained at the end of the experiment is correct. For example, you can follow a recipe to the tee and use the best quality ingredients, but you can still end up with an inedible dish. While non-compliance to GLP erases the legitimacy of a research facility, non-compliance to GMP can result in actual criminal offenses.

So, why is it so important to get the difference between GLP and GMP requirements right? Because several companies have ended up redoing their entire manufacturing process as a result of confusing one for the other.

Concluding Note

Remember, if you want to test the safety or efficacy of a procedure, you should be depending on GLP requirements. But, if you are trying to test lot conformance or lot release, GMP is the one you should be counting on.

Irrespective of what the differences are, non-compliance to either GLP GMP requirements is a sure-shot way to undermine the reputation of your company or the contract lab services that you have engaged to carry out your testing.