Good Laboratory Practices, GLP, Quality Management System

Good Laboratory Practices (GLP)

A set of principles used to ensure the quality, consistency, accuracy and integrity of a non clinical laboratories is called Good Laboratory Practices or GLP. These non clinical laboratories do the research and marketing work for the products regulated by the government. Good Laboratory Practice is normally associated with pharmaceutical industry. Non-clinical laboratories usually perform experiments of new products on animals before final approval for the usage on human beings. Good Laboratory Practices are also applied to other industries or service providers such as color & food additives, food contamination limits, packaging, and medical devices.

The facility conducting regulatory studies must comply with GLP for the following safety tests:

  • Pharmaceutical
  • Agro-chemical
  • Veterinary Medicines
  • Industrial & Chemical
  • Cosmetic
  • Food Additives
  • Biocides

Key Elements

  • Organizational and Personnel.
  • Quality Assurance Program.
  • Facilities conducting regulatory safety tests.
  • Medical Apparatus, Materials, and Specimens.
  • Test and Reference Materials / Substances.
  • Test study performance.