GMP vs GLP
“GMP” is Good Manufacturing Practices, and “GLP” is Good Laboratory Practices. Both the GMP and the GLP are regulations that are governed by the Food and Drug Administration (FDA). These regulations are imposed for ensuring the safety and integrity of drugs.
When comparing the GLP and the GMP, the former one is considered to be less costly and less onerous. While the Good Laboratory Practices is applied for non-clinical laboratory studies, the Good Manufacturing Practices is applied for products that are developed for use by human beings.
The FDA had come forward with a proposal in 1976 for regulating the Good Laboratory Practices after certain irregularities were found in the non-clinical studies. The GLP regulations were coded in 1978 as 21 Code Federal Regulations Part 58. The Good Manufacturing Practice was established in 1963 21 CFR Part 211 as the current Good Manufacturing Practice for pharmaceutical products.
The areas that come under the Good Laboratory Practices are: personnel and organizational, testing facilities, equipment, testing and controls, records, reports, and protocol for and conduct of non-clinical labs.
The areas that come under GMP are: facilities and buildings, equipment, production, process control, packaging and labeling, laboratory controls, and returned/salvaged drug products.
When considering GMP certificates, it is given to those who are engaged in biological, biopharmaceutical, pharmaceutical development, and manufacturing industries. These entities will get the Good Manufacturing Practices certification. For getting the certification, one has to complete four training courses.
The Good Laboratory Practices certification is for laboratory settings. Just like the GMP certification, one has to complete four courses for GLP certification.
Summary:
1.“GMP” is Good Manufacturing Practice, and “GLP” is Good Laboratory Practice.
2.While Good Laboratory Practice is applied to non-clinical laboratory studies, the Good Manufacturing Practices is applied for products that are developed for use by human beings.
3.The GLP regulations were coded in 1978 as 21 Code Federal Regulations Part 58. The Good Manufacturing Practise was established in 1963 21 CFR Part 211 as current Good Manufacturing Practice for pharmaceutical products.
4.GMP certificates are given to those who are in compliance within biological, biopharmaceutical, and pharmaceutical development, and manufacturing industries. These entities will get the Good Manufacturing Practices certification.
5.The areas that come under GMP are: facilities and buildings, equipment, production, process control, packaging and labeling, laboratory controls, and returned/salvaged drug products.
6.The GLP regulations were coded in 1978, and the Good Manufacturing Practices was established in 1963.