GLP and GMP requirements are often thought of as interchangeable. And while it is true that the differences are extremely nuanced, these differences are also crucial. If you want to get a market clearance for your products from the FDA, you must understand the differences between GLP and GMP requirements.
Confusing these two might, even in the best of circumstances, lead to a ton of extra work. In the worst-case scenario, it could prevent you from taking your product to market, thus costing you huge sums of money in lost revenue alone. So, for your convenience, this article will attempt to make the differences between GLP and GMP requirements clear.
What Is GLP Requirement?
GLP stands for Good Laboratory Practice. These are some principles in a laboratory setting meant to control the quality and integrity of laboratory studies that are non-clinical.
What needs to be stressed here is the term “non-clinical.” GLP principles are not imposed on clinical laboratory studies. Non-clinical laboratory studies refer to those studies which involve all other living organisms except humans. This might include even plants or microorganisms. Clinical laboratory studies, on the other hand, have human subjects. Instead of Good Laboratory Practice requirements, Good Clinical Practice (GCP) requirements are used to control the quality of clinical experiments.
The key difference between GLP and GCP is that GLP requirements are decided by a Study Director, who is a single individual. He or she is in charge of making sure that the non-clinical laboratory studies follow the quality standards set by the GLP. In the case of GCP, there is no singular individual who makes these rules. GCP guidelines are mostly set by the Medicines and Healthcare products Regulatory Agency (MHRA).
Learn More About GLP
GLP, however, does not provide a scientific standard. This means one cannot automatically assume that a study that has been conducted under the GLP guidelines is supposed to yield accurate results. Good Laboratory Practices do not claim to set forth any scientific standards.
These guidelines are meant to make sure that data collection and data analysis are done correctly. They also govern the way that the study is conducted, and the ethics of reporting the results. The ultimate result of the experiment is not guaranteed to be correct just because the researchers have abided by the GLP requirements.
Good Laboratory Practices requirements are merely meant to provide the assurance that the non-clinical study was conducted in the correct quality-controlled conditions. One can think of the GLP principles like a recipe book.
You can follow a recipe to the tee but still produce a terrible dish at the end. The recipe book itself cannot guarantee you delicious results. Similarly, GLP does not guarantee the end result. It simply controls the quality of the means that it took you to reach that end.
What Is the GMP Requirement?
GMP stands for Good Manufacturing Practice. The operations, design, and monitoring of the manufacturing processes and facilities are governed by GMP requirements. This obviously sets GMP radically apart from GLP. GLP is confined to the laboratory setting whereas GMP has more to do with getting a market clearance.
The most important factor that sets Good Manufacturing Practices requirements apart is that, unlike the GLP guidelines, GMP is legally enforceable. It governs whether the food or drug that is being released in the market has been manufactured and packaged following the correct processes. Unless GMP requirements are followed, the product cannot be launched into the market and sold to customers.
Not abiding by GMP requirements has severe ramifications for the manufacturer. If it is later discovered that these requirements had not been followed during the manufacturing process, the product can actually be withdrawn from the market. The manufacturer might even receive jail time for not following these GMP practices, if deliberate negligence can be proven.
Key Differences Between GLP and GMP Requirements in Laboratory Testing:
- GMP requirements have real-life implications whereas GLP requirements are confined to the laboratory setting. The failure to follow GLP requirements has no outright legal consequences. Whereas, not following GMP requirements can even lead to imprisonment if deliberate negligence during the manufacturing process can be proven. So, confusing GLP and GMP requirements can have dire consequences if you are a manufacturer of medicinal drugs or food products. Your focus should be on getting a market clearance by religiously following the GMP requirements.
- As a logical follow-up to the first point, the scrutiny that goes into maintaining GMP requirements is justifiably higher than that which goes into maintaining GLP requirements. In the case of GLP, there is a single Study Director who maintains these standards. He is the one who maintains a record with appropriate time stamps. In the case of GMP, a single staff member is not responsible for the scrutiny. The records are signed by the manufacturing body and also the quality control personnel.
- As mentioned before, the Study Director is a single person who is responsible for monitoring whether the non-clinical experiment that is being carried out is following the GLP requirements. However, since the failure to follow GMP requirements actually has legal consequences, the FDA itself is involved in setting up these minimum requirements and then monitoring the manufacturing process.
- The most obvious difference between GLP GMP requirements is that they aren’t even valid in the same fields. For example, GLP requirements are essentially followed in laboratory studies of toxicology, pharmacology, and biocompatibility. GMP, on the other hand, concerns the manufacturing of drugs and food products that are supposed to be released in the market eventually.
In Conclusion
GLP GMP requirements, at the end of the day, have very different real-life applications. The periods of maintenance of GLP and GMP records are also different. Since GLP is concerned with non-clinical laboratory studies. The records have to be maintained for 5 years (from the date of the registration process). The GMP records, however, must be maintained for at least 1 year after a released batch of products has expired.
If you are trying to conduct your experiments in optimal conditions, GLP requirements are what you should be focusing on. But if getting a market clearance on your products is your goal, your focus should be on GMP requirements instead.
