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GXP Inspection & Lab Accreditation
Laboratory Accreditation
Food, Drugs & Cosmetics
Current Status
GXP Inspection & Lab Accreditation
Current Status
【Update Date:
2022-04-07
】
unit:品質監督管理組
To effectively leverage testing resources of private laboratories, ensure the quality and credibility of commissioned testing activities, and expand testing capacities, TFDA implemented a proactive and free accreditation program for private laboratories. The scope of TFDA laboratory accreditation includes tests for food, drugs, medical devices and cosmetics. As of 2021, the numbers of accredited laboratories and tests increased to 138 laboratories and 1,749 tests items respectively. 91 of those were food testing laboratories while 28 were drugs testing laboratories, 4 were medical devices testing laboratories and 15 were cosmetic testing laboratories. The accreditation program helped to establish laboratories with adequate testing capacity and credibility to meet testing requirements for emergencies and sudden events.
To effectively monitor and manage accredited test laboratories and establish a system for assessing the truthfulness of test data, in 2021, TFDA audited 133 accredited test laboratories, of which 98 of the audits were first-time audits, expansion of test items, change of test items, permit extension, and surveillance audits, while 35 of the audits were unannounced.