GLP was first introduced in New Zealand and Denmark in 1972, and later in the US in 1978 in response to the Industrial BioTest Labs scandal. It was followed a few years later by the Organization for Economic Co-operation and Development (OECD) Principles of GLP in 1992; the OECD has since helped promulgate GLP to many countries.
GLP applies to non-clinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals) to man, animals and the environment. [1] GLP, a data quality system, should not be confused with standards for laboratory safety – appropriate gloves, glasses & clothing to handle lab materials safely. The principles of GLP aim to ensure and promote safety, consistency, high quality, and reliability of chemicals in the process of non-clinical and laboratory testing. But, GLP is not limited only to chemicals. It applies to medical devices, food additives, food packaging, colour additives and other non-pharmaceutical products or ingredients as well.
GLP principles include:-
Organization and Personnel
- Management-Responsibilities
- Sponsor-Responsibilities
- Study Director-Responsibilities
- Principal Investigator-Responsibilities
- Study Personnel-Responsibilities
Quality assurance program
- Quality Assurance Personnel
Facilities
- Test System Facilities
- Facilities for Test and Reference Items
Equipment, reagents and Materials
Test systems
- Physical/Chemical
- Biological
Test & Reference items
Standard operating procedures
Performance of Study
- Study Plan
- Conduct of Study
Reporting of results
Archival – Storage of Records and Reports