Follow
To the uninitiated, the difference between GMP and GLP can be a tough nut to crack. But as the names suggest, it is a no-brainer to uncover that they both deal with laboratory testing and ensuring the safety and integrity of drugs and chemical products. These terms often confuse many people and it is time we shed some light on what they actually entail.
A common denominator about these two regulations is that they are both regulated by the Food and Drug Administration (FDA). But apart from that, they are as different as heaven and earth. What aspects and factors distinguish them from each other and what characteristics can distinguish GLP from GMP in detail? Below are some simple tips to distinguish between GMP and GLP.
Good Manufacturing Practices (GMP) are important regulations that act as benchmarks that enable the relevant food and drug regulatory authorities to know whether stellar manufacturing standards have been followed to the letter. It covers the entire process of manufacturing pharmaceutical or chemical products, including the facilities that contain the equipment and processes used in manufacturing.
Good Laboratory Practice (GLP) test rules are established to inspect each step of the study and ensure that the study has an exceptional and expected quality assurance compliance. It is safe and correct to say that GLP regulates and conducts safety and efficacy testing in any study.
Before starting any laboratory study, there should be a robust standard operating procedure (SOP) drafted by professionals and qualified experts. In case of GLP, SOP should be approved by laboratory management. On the other hand quality control unit is responsible for GMP SOP approval.
In Good Laboratory Practice, each study has a protocol that clearly outlines the study goals and the plan to follow. This protocol should be approved by all relevant parties, especially the study sponsor and the study director. When it comes to GMP requirements, there is no need for test-specific protocols because standard written procedures are followed.
There is a wide array of preparation, methods, calibrations, and other processes required for any study. GLP regulations demand that the signatures and initials of all personnel conducting these processes be noted in addition to completion dates. If records are used to obtain a marketing permit, they should be securely archived for not less than five years from the date of registration or two years after testing.
As per GMP, dual-control of all processes and records is mandatory. There are two parties involved, namely the technicians who operate the procedures and the verification staff whose job it is to check each step of the processes. GMP regulations demand that both parties’ initials and signatures should be on all records. It is important to add that records are maintained for one year after the expiry of the product and need not be archived.
This is a critical aspect that can confuse many people but to be acutely aware of the difference between these two factors, you only need to understand the methods of drug development. GLP is more concerned with pharmacology, toxicology, biocompatibility and other related areas. These are areas whose primary focus is to supplement product marketing or research applications.
But the priority in GMP regulation is the entire process and it is only concerned with whether each product on the production roll complies with the pre-defined regulations.
Both Good Manufacturing Practice and Good Laboratory Practice are important in any drug or chemical manufacturing process; There should be a clear line between them. It goes without saying that every hard work can be an exercise in futility if one is confused for the other. It is therefore important that the personnel involved learn how to tell the difference between GMP and GLP to avoid redoing entire processes or, worse, compliance issues.
