Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) are regulations governed by the Food and Drug Administration (FDA) to ensure the safety and integrity of drugs marketed to the public. The difference in GLP and GMP is the time of implementation in the life cycle of drug development. While GLP ensures the quality and integrity of the nonclinical laboratory data submitted to the FDA to support the application of a new product, GMP ensures that the safety, efficacy, quality and integrity of the product are maintained in every manufactured lot.
Rationale Behind GLP
Compounds that may become potential lifesaving drugs generally start their life cycles in a research laboratory, where they first undergo in vitro testing. These experiments indicate their possible effectiveness against a particular disease. The next step involves in vivo testing, which provides data that these pharmacological compounds are effective in animals and do not cause toxicological or other side effects. Data generated in these nonclinical studies is submitted to the FDA, as it provides background information on the new drug.
In 1976, the FDA published a proposal for establishing regulations for Good Laboratory Practices (GLP) after it found inconsistencies in data and deficiencies in the manner in which nonclinical studies were conducted. GLP regulations were established in 1978 as 21 Code of Federal Regulations (CFR) Part 58.
Rationale Behind GMP
GMP came into existence in 1963, long before GLP. Thalidomide, marketed in Europe as a sedative and as treatment for morning sickness in pregnant women, was not approved in the U.S. because it failed to meet the pharmacology and toxicological standards of the FDA. The drug turned out to be highly teratogenic, resulting in the birth of thousands of malformed babies in Europe. This incident aroused public interest in drug safety and regulation, and laid the foundation for the requirement of GMP. FDA regulations require manufacturers to provide evidence of effectiveness and safety of a proposed drug, and to obtain FDA approval before marketing the drug. GMP was established in 1963 as 21CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals.
Under the GLP and GMP Umbrella
The FDA requires that the drug manufacturers follow all the regulations stated in 21CFR58 and 21CFR211. The broad areas that come under GLP regulations are organisation and personnel; facilities; equipment; testing facilities operation; test and control articles; protocol for and conduct of a nonclinical laboratory study; and records and reports. Noncompliance in any of these areas can result in the disqualification of the testing facility.
Similarly, regulations under GMP encompass the following: organisation and personnel; buildings and facilities; equipment; control of components and drug product containers and closures; production and process controls; packaging and labelling control; holding and distribution; laboratory controls; records and reports; and returned and salvaged drug products.
Both the GLP and GMP are revised periodically by the FDA. Drug manufacturers are required to adhere to the current GLP and GMP regulations.