Good Laboratory Practices (GLP)
Quality Management System
Good Laboratory Practices or GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies. The term GLP is most commonly associated with the pharmaceutical industry and the required non-clinical animal testing that must be performed prior to approval of new drug products. However, GLP applies to many other non-pharmaceutical agents such as color additives, food additives, food contamination limits, food packaging, and medical devices.
Good Laboratory Practices (GLP) only applies to non-clinical studies and testing. It does not apply to clinical studies. This is extremely important because clinical studies are governed by Good Clinical Practices (GCP), the Declaration of Helsinki, and other regulations intended to protect human participant safety. Furthermore, much of the GLP structure depends on the roles and responsibilities of the Study Director, a single individual that is responsible for the oversight and execution of all aspects of the non-clinical study. Study Directors do not exist in the clinical study arena, thus GLP principles cannot be applied effectively in the clinical setting.
Any test facility which conducts, or intends to conduct, regulatory studies must comply with good laboratory practice (GLP) regulations when carrying out safety tests on:
- Pharmaceuticals
- Agrochemicals
- Veterinary medicines
- Industrial chemicals
- Cosmetics
- Additives for human food and animal feed
- Biocides
Key Elements of GLP
- Organisation and Personnel.
- Quality Assurance Programme.
- Facilities.
- Apparatus, Materials, Reagents and Specimens.
- Test Systems.
- Test and Reference Substances.
- Standard Operating Procedures.
- Performance of the Study.
