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