Good Laboratory Practice

Good Laboratory Practice (GLP) is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies. The principles of GLP were formulated to promote the quality and validity of test data and are applied to non-clinical safety studies of pharmaceuticals, pesticides, cosmetics, veterinary drugs, and chemicals.

History

The concept of GLP originated in the United States in the 1970s, following a series of problems with the way safety studies were conducted, which led to questions about the integrity of data being submitted to regulatory agencies. In response, the U.S. Food and Drug Administration (FDA) established the first GLP regulations in 1978. The Organisation for Economic Co-operation and Development (OECD) adopted its own set of GLP principles in 1981, which have since been adopted by its member countries and used as a benchmark for GLP practices worldwide.

Principles of GLP

The core principles of GLP focus on the organization, process, and conditions under which laboratory studies are planned, performed, monitored, recorded, reported, and archived. These principles include:

• Organization and Personnel: Ensuring that personnel are qualified for their roles and responsibilities.
• Quality Assurance: A quality assurance program must be in place to monitor the compliance of the study with GLP.
• Facilities: Adequate facilities must be provided to avoid contamination and ensure the welfare of laboratory animals.
• Equipment: Equipment must be appropriately designed, maintained, and calibrated.
• Materials and Reagents: All materials and reagents should be labeled and their quality or grade specified.
• Test Systems: The proper management, characterization, and care of test systems, including animals and plants.
• Test and Reference Items: Proper handling, identification, and storage of test and reference items.
• Standard Operating Procedures (SOPs): SOPs must be in place for all aspects of the study.
• Performance of the Study: The study must be conducted in accordance with the approved plan and SOPs.
• Reporting of Study Results: Reports must fully describe the study, results, and conclusions.
• Storage and Retention of Records and Materials: Adequate procedures must be in place for the archiving and retrieval of records and materials.

Implementation and Compliance

GLP compliance is monitored by regulatory authorities in each country. In the United States, the FDA and the Environmental Protection Agency (EPA) are the primary agencies overseeing GLP compliance. In the European Union, each member state has its own competent authority responsible for GLP inspections. The OECD plays a significant role in facilitating the harmonization of GLP standards among its member countries through mutual acceptance of data (MAD), which allows data generated in one OECD member country to be accepted in other member countries, reducing the need for duplicate testing.

Importance of GLP

Adherence to GLP is crucial for the credibility of non-clinical safety data submitted to regulatory agencies. It ensures that the data are scientifically valid, reliable, and reproducible, which is essential for the protection of human health and the environment. GLP also facilitates the mutual acceptance of study data among countries, thereby promoting international trade and reducing the need for duplicate testing.

Good Laboratory Practice Resources
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