Regulations of Medicament Manufacturer Inspection｜第 4 條｜Food and Drug Administration｜Regulation｜In Force
衛生福利部｜v1.0
Last Amended: 2014-02-21
Domestic pharmaceutical manufacturers of the new establishment, relocation, expansion, resumption of operations, or addition of new active pharmaceutical ingredients, dosage forms, processes (packaging and labeling), shall apply for inspection by submitting a fee, along with a completed GMP Accreditation Application Form and the following documents to the central competent health authority: (1) A certificate proving that hardware facilities have passed inspection, or a certificate of factory registration; (2) A completed checklist of general information of a pharmaceutical manufacturer, along with Site Master File (hereafter shortened to “SMF”) containing the items detailed in the checklist. For the inspection referred to in the preceding Paragraph, the central competent health authority may, jointly with the municipal or county (city) competent health authorities, conduct the on-site inspection.