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GLP

Good Laboratory Practice (GLP)

Good Laboratory Practice (GLP) is a quality system concerned with the organisational processing process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. The purpose of the Principles of Good Laboratory Practice is to promote the development of quality test data and provide a tool to ensure a sound approach to the management of laboratory studies, including conduct, reporting and archiving.

The concept of “Good Laboratory Practice” (GLP) originated in the USA in the 1970s because of concerns about the validity of non-clinical safety data submitted to the Food and Drug Administration (FDA) in the context of New Drug Applications (NDA).A number of countries now require manufacturers of industrial chemicals, pharmaceuticals, veterinary drugs, pesticides, cosmetic products, food products, feed additives, etc., to establish through data that use of these products do not pose any hazards to human health and the environment. Non-hazardous nature needs to be established through studies and data, which will be examined by the regulatory authorities of the concerned countries. Good Laboratory Practice (GLP) is a system, which has been evolved by Organisation for Economic Co-operation and Development (OECD) used for achieving the above goals.

Scope:

  • These principles of Good Laboratory Practice should be applied to testing of pharmaceutical products to obtain data on their properties and/or their safety with respect to human health or the environment.
  • Studies covered by Good Laboratory Practice also include work conducted in field studies.
  • These data would be developed for the purpose of meeting regulatory requirements.

GLP principles:

  1. Test Facility Organization and Personnel
  2. Management-Responsibilities
  3. Study Director-Responsibilities
  4. Personnel Responsibilities
  5. Quality assurance program
  6. Quality Assurance Personnel
  7. Facilities
  8. Test System Facilities
  9. Facilities for Test and Reference Items
  10. Equipments, reagents and Materials
  11. Test systems
  12. Physical/Chemical
  13. Biological
  14. Test & Reference items
  15. Standard operating procedures
  16. Performance of Study
  17. Study Plan
  18. Conduct of Study
  19. Reporting of results
  20. Storage of Records and Reports

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