Harmonization of good laboratory practice requirements and laboratory accreditation programs

Area of Science:

• Regulatory Science
• International Standards
• Laboratory Accreditation

Background:

• The Organization for Economic Cooperation and Development (OECD) has worked on harmonizing Good Laboratory Practice (GLP) requirements since 1981.
• Memoranda of Understanding (MOU) agreements promote reciprocal data acceptance and unified GLP standards among member countries.
• International Standards Organization (ISO) 9000 certification addresses quality systems, potentially impacting laboratories conducting GLP studies.

Purpose of the Study:

• To review the progress and impact of international efforts to harmonize GLP requirements.
• To examine the development of GLP accreditation programs in OECD countries, Canada, the US, and the European Community.
• To assess the goals of harmonizing requirements and ensuring confidence in data integrity through inspection and screening.

Main Methods:

• Analysis of OECD/GLP program activities, including workshops and MOU agreements.
• Review of GLP accreditation programs developed by national health and environmental ministries.
• Examination of International Standards Organization (ISO) 9000 certification relevance to GLP studies.

Main Results:

• Several OECD countries have established GLP accreditation programs.
• Canada and the United States are exploring laboratory accreditation for environmental monitoring and GLP studies.
• Common goals include harmonization, recognition of requirements, and confidence in data integrity.

Conclusions:

• International initiatives are progressing towards unified GLP standards and reciprocal data acceptance.
• Laboratory inspection and screening processes aim to build confidence in data integrity.
• The ultimate success hinges on the mutual international acceptance of data produced by sanctioned laboratories.