Handbook of Good Laboratory Practice

The Handbook of Good Laboratory Practice (2nd Edition) is an essential resource for anyone involved in the design, conduct, or oversight of laboratory studies. This comprehensive guide provides a detailed overview of the principles and practices of Good Laboratory Practice (GLP), a quality assurance system that ensures the integrity and reliability of laboratory data.

The Handbook covers all aspects of GLP, from the basics of laboratory organization and management to the specifics of study design, data collection, and reporting. It is intended to be a practical and accessible resource for researchers, laboratory managers, regulators, and other stakeholders in the laboratory community. The Handbook begins by defining the scope and objectives of GLP and explaining the regulatory context in which it operates. It then covers the key elements of GLP compliance, including the responsibilities of the study director, the roles and responsibilities of laboratory personnel, and the requirements for facility and equipment management.

One of the most important aspects of GLP is study design, and the Handbook provides detailed guidance on this topic. It covers the selection of appropriate animal models and test systems, the use of controls and reference materials, and the design of protocols and procedures. The Handbook also provides guidance on the conduct of studies, including the collection and analysis of data and the documentation and reporting of results. In addition to providing guidance on the design and conduct of laboratory studies, the Handbook also covers the management of laboratory data. This includes guidance on the handling and storage of data, the use of computerized systems for data collection and analysis, and the validation and verification of analytical methods.

The Handbook also covers the auditing and inspection of laboratory facilities and operations. It provides guidance on the preparation for and conduct of audits and inspections, as well as the follow-up actions that may be required to address any deficiencies identified.

Finally, the Handbook covers the international harmonization of GLP standards and the role of GLP in ensuring the safety and efficacy of regulated products. It also includes a glossary of key terms and definitions, as well as a list of resources for further information and guidance.

Overall, the Handbook of Good Laboratory Practice (2nd Edition) is an essential resource for anyone involved in the design, conduct, or oversight of laboratory studies. It provides a comprehensive and practical guide to the principles and practices of GLP, and is an invaluable tool for ensuring the integrity and reliability of laboratory data.

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Quality practices for regulated non-clinical research and development

Summary

Good laboratory practice (GLP) is the recognized rule governing the conduct of non-clinical safety studies. They ensure the quality, integrity, and reliability of study data.

This 2nd edition handbook is designed to aid countries in upgrading their laboratories to GLP status. Based on the Organization for Economic Cooperation and Development (OECD) principles of GLP, the handbook provides laboratories and trainers in disease-endemic countries with the technical information necessary to implement the GLP program.