Difference between GMP and GLP : Pharmaceutical Guidelines

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Difference between GMP and GLP

GMP and GLP both are used in pharmaceutical manufacturing facility but both have a lot of differences. GMP covers whole manufacturing facility while GLP covers only quality control laboratory. GMP vs GLP is described here.
To the uninitiated, the difference between GMP and GLP can be a hard nut to crack. But as the names suggest, it is a no-brainer to unravel that they both concerned with laboratory testing and ensuring the safety and integrity of drugs and chemical products. These terminologies often confuse many people and it is about time that we shed some light on what they really entail.

One of the common denominators about these two regulations is that they are both governed by the Food and Drug Administration (FDA). But apart from that, they are as different as the sky and the earth. What aspects and factors set them apart from each other and what characteristics can elaborately differentiate GMP from GLP? Outlined below are some handy tips to show the difference between GMP and GLP.

GMP vs GLP
Good Manufacturing Practices (GMP) are important regulations that serve as yardsticks to enable the relevant food and drug regulatory authority to know whether stellar manufacturing criteria are followed to the letter. This covers the whole process of manufacturing of drugs or chemical products, including the equipment used in the manufacturing and the facility that houses the processes.

Good Laboratory Practice (GLP) testing regulations are put in place to inspect each and every phase of the study and ensure that there is an exceptional and expected quality assurance compliance in the research. It is safe and correct to say that GLP regulates and governs safety and ability testing in any research.

Before any laboratory study can commence, there has to be in place a formidable standard operating procedure (SOP) drafted by professional and qualified experts. In the case of GLP, the SOP should be approved by the laboratory management. On the other hand, the approval of the GMP's SOP is the responsibility of the quality control unit.

In Good Laboratory Practice, every study has a protocol that clearly outlines the aims of the study and the plans to be adhered to. This protocol should be approved by all the relevant parties, especially the study sponsor and the study director. When it comes to GMP requirements, there is no need for testing-specific protocols as standard written procedures are adhered to.

There is a wide array of preparations, procedures, calibrations, and a host of other processes that are necessary for any research. GLP regulations demand that the signatures and initials of all the staff conducting all these procedures be noted down in addition to the completion dates. If the records are used in getting a marketing permit, then they should be securely archived for not less than five years since the date of registration or two years after the testing is done.

In the case of GMP, dual-control of all the processes and records is mandatory. There are two sides involved, namely the technicians running the procedures and the verifying personnel whose job is to vet every step of the processes. GMP regulations demand that the initials and signatures of both parties be on all the records. It is vital to add that records are maintained for a year after the product expires and not necessarily in archives.

This is a critical aspect that may confuse many people but to be acutely aware of the difference between these two factors, you only have to understand the drug development procedures. GLP is more concerned with areas such as pharmacology, toxicology, biocompatibility, plus other related areas. These are the areas whose primary focus is to complement the marketing or research applications of the products.
But GMP regulations area of priority is the entire process and it is only concerned with whether every product that rolls of the production has adhered to the pre-set regulations.

In as far as both Good Manufacturing Practice and Good Laboratory Practice are critical 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. So it is critical that the personnel involved should learn how to tell the difference between GMP and GLP in order to avoid having to re-do entire processes or even worse, compliance problems.





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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