Regulations Governing Accreditation and Outsourced Accreditation Management of Drugs Testing Institutions Article 22
An independent provider shall ensure that the personnel implementing the accreditation procedures possess the necessary pharmaceutical testing related knowledge and proficiency; moreover, the independent provider shall keep a record of the initial and regular assessments conducted on said personnel.The personnel stated in the preceding paragraph, shall attend at least 12 hours of continued education and training course conducted by an institution (body) or civilian institution or group recognized by the central competent health authority every year. Education or training curriculum shall include audit techniques, testing knowledge and skills, and related laws.
中文原文 藥物檢驗機構認證及委託認證管理辦法第22條
受託者應確保其執行認證人員具備藥品檢驗相關知識及能力,並備有受託者對該人員初次及定期評估之紀錄。
前項人員,每年應接受中央衛生主管機關認可之機關(構)或民間機構、團體辦理之繼續教育訓練十二小時以上;其課程包括查核技巧、檢驗知能及相關法令。
前項人員,每年應接受中央衛生主管機關認可之機關(構)或民間機構、團體辦理之繼續教育訓練十二小時以上;其課程包括查核技巧、檢驗知能及相關法令。