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GXP Inspection & Lab Accreditation
Laboratory Accreditation
Food, Drugs, Medical Devices & Cosmetics
Current Status
GXP Inspection & Lab Accreditation
Current Status
【Update Date:
2024-01-05
】
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 accreditation program for private laboratories. The scope of TFDA laboratory accreditation includes tests for food, drugs, medical devices and cosmetics. As of 2023, the numbers of accredited laboratories and tests increased to 132 laboratories and 1,806 tests items respectively. 86 of those were food testing laboratories while 26 were drugs testing laboratories, 4 were medical devices testing laboratories and 16 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, TFDA shall regularly audit the equipment, personnel organization, quality management, operating procedures, testingcapacity, and test records of the accredited testing laboratories and may require the testing laboratories to submit reports of the testing procedures conducted within the accreditation scope. When necessary, TFDA may conduct irregular audit.