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 in which these products are manufactured. Even the medical and drug manufacturing industries have imposed regulations.
GMP and GLP are two imposed regulations by the FDA to keep the quality of drugs and manufacturing units.
Though both regulations by the FDA for drugs control different aspects and manufacturing units, knowing which regulation is used for the drugs you consume is important.
Key Takeaways
- GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) are two quality management systems used in the pharmaceutical industry.
- While GMP focuses on ensuring consistent quality in the manufacturing process, GLP focuses on maintaining the reliability and validity of data generated from laboratory experiments.
- Both GMP and GLP are essential in ensuring the safety and efficacy of drugs and healthcare products, and they have strict regulatory requirements that manufacturers and laboratories must follow.
GMP vs GLP
Good Manufacturing Practice (GMP) focuses on the manufacturing process, ensuring that the final product is safe, effective, and consistent in quality. Good Laboratory Practice (GLP) focuses on the laboratory testing phase of drug development, ensuring that it is reliable, accurate, and traceable.
GMP, or Goods Manufacturing practice, 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. 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 practice of pharmaceuticals. These drugs are not to be used for human consumption. Even this also requires a four-course test clearance.
Comparison Table
| 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 for the drugs that are developed for humans. | These are the regulations set by the FDA for laboratory practice of developed drugs. 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 to regulate 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 personnel, plant and machinery, 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 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 drug industries. It checks the quality of the drugs or chemicals being produced and the process and types of equipment used for production.
All industrial companies manufacturing such products need to have a GMP certificate to prove the 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 quality control unit governs the approval of GMP’s SOP. Maintaining dual control of all procedures and records is also a must.
These records must also contain the initials and signatures of the concerned authorities.GMP is concerned about whether each product 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 for the laboratory practice on drug and other chemical manufacture.
It is the regulation for each step involved in the study and 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 aim 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 focused on developing 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 for Goods Laboratory Practise. Though they are both set by the FDA, they have considerable differences.
- Gmp and GLP are both regulations and 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 are not meant for human use.
- GMP was proposed by the FDA in 1963 to regulate the practices of non-clinical laboratories. The need to propose such regulations was 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 pharmaceutical products used within a laboratory.
- The two certifications or regulations pertain to different purposes and applications. GMP pertains to personnel, plant and machinery along with the 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. GLP also regulates the control of the quality of the testing practice.
- A GLP costs less and is more cumbersome for companies to obtain than GMP. But a company prefers to attain both certificates to show the quality test of the drugs being produced or manufactured.
- https://onlinelibrary.wiley.com/doi/abs/10.1002/qaj.294
- http://search.proquest.com/openview/b0aaea873d2bdab7ea69226aec4a62fe/1?pq-origsite=gscholar&cbl=52720
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