Good Laboratory Practice

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The Principles of Good laboratory Practice, hereinafter GLP, is to promote the quality and validity of test data used for determining the safety of chemicals and chemical products. The OECD Principles of GLP were adapted in 1981 and amended in 1997. GLP compliance monitoring program was introduced into the Japan’s Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. in March 1984. The GLP program is aligned with the OECD Principles of GLP.
GLP program is conformity assessment of test facilities in the area of such as management, apparatus, study plans, internal inspections, quality assurance, and test results. Test facilities should be inspected every three years to maintain their statutes of GLP compliance.

GLP compliance test facilities in the area of biodegradation, bioaccumulation and partition coefficient are listed in this Directory.To the Directory page (Japanese only) (Link to METI Web site)

Notifications

Ministry of Economy, Trade and Industry (METI), Ministry of Health, Labor and Welfare (MHLW) and Ministry of the Environment (MOE) published notifications from their Bureau Director Generals

• GLP criteria for new chemical substances test facilities [PDF:164KB]
• Test data use in assessing new chemical substances [PDF:157KB] (Japanese only)
• Partial Revision of Test data use in assessing new chemical substances [PDF:184KB] (Japanese only)

Relevant documents

Operational Principles of Chemical Substances GLP [PDF:110KB] (Japanese only)

• Guidance on preparing documents for GLP compliance inspection (Japanese only)

  Form 1[PDF:383KB] (Japanese only)

  Form 2 ~ 6, Reference 1 ~ 3[PDF:138KB] (Japanese only)

Relevant Notification

Testing methods for new chemical substances[PDF:1.79MB] (Japanese only)

Relevant documents are available at the Japanese page
To Japanese page