statement

statement

公告日期: 2016/01/19

Taiwan Accreditation Foundation (TAF) is the national Good Laboratory Practice (GLP) Compliance Monitoring Authority (CMA) in Taiwan, officially designated by the Environmental Protection Administration (EPA), the Council of Agriculture (COA) and the Industrial Development Bureau (IDB), Ministry of Economic Affairs (MOEA). Since 2004, under supervision of the Bureau of Standards, Metrology, and Inspection (BSMI), MOEA, TAF began to establish a national GLP compliance monitoring program.

Taiwan's "National GLP Compliance Monitoring Program", launched in 2006, is operated by TAF in accordance with the OECD (Organization for Economic Cooperation and Development) GLP Guidance Documents for Compliance Monitoring Authorities, i.e. "No 2: Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice", "No 3: Revised Guidance for the Conduct of Laboratory Inspections and Study Audit" and "No 9: Guidance for the Preparation of GLP Inspection Reports", as well as the Advisory Documents of the Working Group on GLP, i.e. "No 12: Requesting and Carrying Out Inspections and Study Audits in Another Country". TAF performs inspections and study audits to GLP test facilities. They will be registered in the GLP compliance registration list once they are deemed to be compliant with OECD Principles. TAF also cooperates with the receiving authorities of GLP studies. A test facility that has been registered by TAF after inspection is guaranteed to be compliant with the OECD Principles on GLP, and shall be monitored by TAF on regular basis.

TAF has been participating in the annual meeting of the OECD Working Group on GLP as an ad hoc observer since 2006. Three TAF staff had participated in the OECD GLP Inspector Training Course.

On 3 February 2010, a "Letter of Confirmation" was signed by the Taipei Economic and Cultural Representative Office in the U.S. (TECRO) and the American Institute in Taiwan (AIT). It is a confirmation that Taiwan has a GLP program for pesticides and industrial chemicals that US EPA recognizes as compatible to the US EPA's. In light of this, any test facility in Taiwan that has been inspected by the TAF and is in compliance with OECD Principles of GLP is accepted by the US EPA if they generate pesticides and industrial chemical data for US EPA submission.

The ultimate goal of establishing the GLP program is to become an adherent to the OECD Mutual Acceptance of Data (MAD) System for GLP, so as to accommodate the requests of receiving authorities and to serve the needs of the GLP studies related market.

點閱次數:5001 最後更新時間:2016/01/19維護單位:TAF財團法人全國認證基金會