While the provided references don't explicitly list 5 fundamental points of Good Laboratory Practice (GLP), we can extract key aspects of GLP compliance from them to address this question. GLP emphasizes quality and reliability in non-clinical health and environmental safety studies. Based on the documentation provided, here are 5 fundamental points:
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Comprehensive Documentation: This is a cornerstone of GLP. All aspects of the study, from protocol to raw data and final report, must be thoroughly and accurately documented. "Laboratory documentation should follow the principles that are explained in this guideline." This ensures traceability and reproducibility.
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Standard Operating Procedures (SOPs): SOPs are crucial for standardizing processes and ensuring consistency. The reference mentions "An SOP that describes the sampling steps should be in place." This applies to all procedures, not just sampling, guaranteeing that tests are performed uniformly.
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Proper Testing Protocols: GLP mandates adherence to pre-defined and approved testing protocols. While the reference only mentions "Testing", it implies adherence to detailed protocols covering all aspects of the tests, ensuring the reliability of the generated data. This includes specifying the methods, materials, and acceptance criteria.
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Ongoing Stability Program: This aspect ensures the integrity of test items and reference standards over time. This is essential for maintaining the validity of the study results.
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Technical Transfer of Testing Methods: This point highlights the importance of validated and transferable methodologies. Successful technical transfer ensures that the test method can be reliably performed in different laboratories or by different analysts while maintaining consistent results.
In summary, GLP relies heavily on documented procedures, standardized processes, robust testing methodologies, and maintaining the stability of materials to ensure the integrity and reliability of study data.
