The Principles of Good Laboratory Practice (GLP) establish rules and criteria for a quality system that oversees the organizational processes and conditions in which non-clinical health and environmental safety studies are planned, conducted, monitored, recorded, reported, and archived.
[5] These regulations were developed in response to concerns about the reliability and consistency of safety data used in assessing the potential risks of chemicals and products to humans and the environment.
[7] IBT, a contract laboratory based in Northbrook, Illinois, conducted research for the United States government and various chemical and pharmaceutical companies, both from the U.S. and abroad, and submitted toxicology data to several federal agencies, covering a wide range of products including drugs, insecticides, herbicides, food additives, pesticides, cosmetics, and cleaning products.
[13][14][15] The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act.
[17] Conducting these studies with rigorous adherence to scientific principles and quality control is crucial, as the decisions based on their outcomes directly affect human health and safety.
Compliance with GLP regulations helps to protect the safety and welfare of humans and animals involved in studies and contributes to the overall integrity of scientific research in the development of FDA-regulated products.
[32] Proposed modifications to the GLP Quality System include additional responsibilities for testing facility management and SOP maintenance, along with expanded definitions applicable to all nonclinical laboratory studies, aiming to enhance roles and functions aligned with the revised testing facility definition and to establish a framework for improving data reliability in regulatory decision-making.
[30][31] The EPA's Good Laboratory Practice Standards (GLPS) compliance monitoring program guarantees the accuracy and reliability of test data submitted to the Agency to support pesticide product registration under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), section 5 of the Toxic Substances Control Act (TSCA), and in accordance with testing consent agreements and rules issued under section 4 of TSCA.
It establishes the requirements for conducting studies and generating data used for the registration of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
This could include studies conducted for assessing the safety of industrial chemicals, pharmaceuticals, food additives, and other substances subject to EPA regulation.
Depending on the location or governing rules in an OECD-member country, the OECD Principles of GLP might also extend to non-clinical safety testing of other regulated items, like medical devices.
During the review process, the submitted data undergoes verification to ensure compliance with Good Laboratory Practice (GLP) standards.
[34] Harmonizing national approaches to chemical regulation offers several benefits: it streamlines requirements for industry, provides governments with a common framework for collaboration, and reduces trade barriers.
This recognition also extends to some non-OECD countries that fully adhere to the mutual acceptance of data (MAD) under OECD Council Decision C(97)114/Final, including Brazil, India, Malaysia, Singapore, and South Africa, as well as Argentina for industrial chemicals, pesticides, and biocides only.
[36] The Principles of Good Laboratory Practice (GLP) ensure the quality and accuracy of data in chemical testing and help prevent fraud.
[4][35][39] Directive 2004/9/EC mandates EU/EEA countries to designate GLP inspection authorities and includes requirements for reporting and mutual acceptance of data within the internal market.
Having common GLP standards also makes it easier to share information and prevents trade barriers, while helping to protect human health and the environment.