Having a set of regulations in any field of manufacture is important. It is necessary to keep the product quality in check and the environment that these products are being manufactured in. Even the medical and drug manufacturing industries have regulations imposed.
GMP and GLP are two such imposed regulations by the FDA to keep the quality of drugs and manufacturing unit. Though they are both regulations by the FDA for drugs, they control different aspects and different manufacturing units. It is important to know which regulation is used for the drugs that you consume.
GMP or Goods Manufacturing Practise is the regulation imposed in 1963 for regulating the non-clinical practice. It is for non-clinical laboratory practices and the drugs developed under these are for human consumption. The pharmaceuticals must pass the four-course test to obtain the certification.
GLP or Goods Laboratory Practise is the regulation imposed in 1976 as a subordinate of GMP. It is the regulation to maintain the laboratory practise of pharmaceuticals. These drugs are not to be used for human consumption. Even this also requires a four-course test clearance.
The difference between GMP and GLP is that GMP is the regulations set by the FDA for the non-clinical laboratory practices and the drugs consumed by humans. Whereas, GLP is for laboratory practices of drug testing.
Comparison Table Between GMP and GLP
|Parameters of Comparison||GMP||GLP|
|Abbreviation for||Good Manufacturing Practise||Good Laboratory Practise|
|Meaning||It is the regulations set by the FDA for non-clinical laboratory practices. It is often for the drugs that are developed for humans.||These are the regulations set by the FDA for laboratory practice of the drugs that are developed. These drugs are the ones that are developed for testing before being applied for human use.|
|Origin||It was proposed by the FDA in 1963 for the regulation of non-clinical laboratory practices. It is because some irregularities were found in a few non-clinical studies.||It was made after the proposal and establishment of GMP in 1976 for pharmaceutical products.|
|Pertains to||GMP pertains to personal, plant and machinery along with production and packaging processes.||GLP pertains more to lab testing, managing records and data related to each practice. It also pertains to quality control during lab practice.|
|Cost||It comparatively costs more than GLP to obtain a GMP certificate from the FDA.||It is less costly and cumbersome than a GMP certificate.|
What is GMP?
GMP are important regulations that are used to govern the food and drugs industries. It not only checks the quality of the drugs or chemicals being produced but also the process and types of equipment used for producing.
All industrial companies manufacturing such products need to have GMP certificate to prove their quality of a product. They have to undergo and clear a four-course test to obtain the certificate.
Obtaining a GMP certificate or authority is said to be quite expensive. The approval of GMP’s SOP is governed by the quality control unit. It is also a must to maintain a dual control of all procedures and records.
These records must also contain the initial and signature of the concerned authorities.GMP is concerned about whether each product that is rolled out of the unit is manufactured adhering to all the regulations set for them.
What is GLP?
GLP are also regulations set for the food and drugs industries by the FDA for research on the drugs in a laboratory. So it is the regulations set for the laboratory practice on drug and other chemical manufacture.
It is the regulation for each step involved in the study along with the assurance of expected and exceptional research quality. So before any laboratory study can commence, one should have a GLP standard operating procedure drafted and approved.
According to GLP, every study should clear the protocols set that aims at the outline of the study or research. These protocols need to be approved by the concerned authorities, especially the study sponsor.
GLP is more concerned about the areas that are focused on the development of the marketing and research applications of the industry.
Main Differences Between GMP and GLP
- The two terms GMP and GLP are abbreviations of different terms. Gmp is the abbreviation for Good Manufacturing Practise whereas GLP is the abbreviation for Goods Laboratory Practise. Though they are both set by the FDA, they have considerable differences among them.
- Gmp and GLP are both regulations standards set by the FDA. The difference, however, is the purpose of setting them. Gmp is the regulations set by the FDA for non-clinical laboratory practices of usage and development of drugs. The drugs that are manufactured and developed are for human use. On the other hand, GLP is the regulations set for laboratory practice of these drugs. The drugs developed here are for testing and experimenting in the laboratory alone and not meant for human use.
- GMP was proposed by the FDA in 1963 for regulating the practices of non-clinical laboratories. The need to propose such regulations were instigated because many irregularities were found within the non-clinical studies of drugs. The establishment of GLP was after the GMP. In 1976, GLP was established for pharmaceuticals products used within a laboratory.
- The two certification or regulations pertain to different purposes and applications. GMP pertains to personal, plant and machinery along with production and packaging processes of the manufactured drugs. On the other hand, GLP pertains more to lab testing. It is also regulations for the records and data management of each practice. Control of quality of testing practise is also regulated by GLP.
- A GLP costs less and is cumbersome for companies to obtain than GMP. But a company prefers to attain both the certificates to show the quality test of the drugs being produced or manufactured.
GMP and GLP are both regulations set by the FDA to govern the food, drugs and chemical manufacturing. It regulates the quality, procedures and equipment used for the manufacturing of the drugs. The distinction between the two is that GMP is for the drugs manufactured for human consumption whereas GLP is for research and study of laboratory drugs.
Table of Contents