School of Pharmacy


Good laboratory practice (GLP)

Good Laboratory Practices (GLP) is a part of GXP systems which includes, but not limited to, Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) and of recent Good Clinical Laboratory Practice (GCLP).

GLP is a quality system dealing with non-clinical analytical and safety studies on test items such as pharmaceutical and cosmetic products, complementary and alternative medicines, and veterinary and biotechnological products. In a typical pharmaceutical manufacturing environment, a GLP laboratory is an integral part of GMP.

GCLP applies the principles established under GLP for data generation used in regulatory submissions to the analysis of samples from a clinical trial while ensuring the objectives of the GCP principles are carried out. This ensures the integrity and reliability of data generated by an analytical laboratory.

Benefits of GLP


glp

Reliability, integrity, traceability and reproducibility of the data generated from analysis of raw materials and formulations intended for human or veterinary use is critical to ensure their safety and efficacy.

Compliance to GLP ensures use of systems and procedures to facilitate this requirement in a controlled environment.

GLP compliant status means that all analytical studies are carried out by trained staff, using calibrated instruments, validated methods, with the highest attention to detail, and following documents acceptable to regulatory authorities around the world.

This:

  • Enhances credibility of data and reporting
  • Promotes acceptance of data internationally
  • Reduces technical barriers to trade
  • Provides improved and most cost effective facility
  • Better traceability and reproducibility of data