Regulations of Medicament Manufacturer Inspection｜第 3 條｜Food and Drug Administration｜Regulation｜In Force
衛生福利部｜v1.0
Last Amended: 2014-02-21
Inspections of medicament manufacturers shall be categorized as following: (1) Inspections of the new establishment, relocation, expansion, resumption of operations, or addition of new active pharmaceutical ingredients, dosage forms, processes (packaging and labeling), products; (2) Inspections of the follow-up management of medicament manufacturers; (3) Regional routine inspections; (4) Other types of inspections. Domestic medicament manufacturers mentioned in Subparagraph 1 of the preceding Paragraph, their hardware facilities and sanitary conditions must comply with regulations of Part 2 of the Standards for Medicament Factory Establishments and the Factory Management Guidance Act, and shall be subject to inspection by the competent industry authorities and municipal or county (city) competent health authorities; their software facilities and sanitary conditions must comply with regulations of the Pharmaceutical Good Manufacturing Practice, and shall be subject to inspection by the central competent health authority in accordance with regulations of Article 4 or Article 6. Foreign medicament manufacturers mentioned in Subparagraph 1 of Paragraph 1 must comply with regulations of the Pharmaceutical Good Manufacturing Practice, and shall be subject to inspection by the central competent health authority in accordance with regulations of Article 5 or Article 7. For inspections mentioned in Subparagraph 2 of Paragraph 1, domestic medicament manufacturers shall be inspected in accordance with regulations of Article 8, and foreign medicament manufacturers shall be inspected in accordance with regulations of Article 9. Firms approved by the central competent health authority to manufacture medicaments for development, if applications for marketing of their products are not made, regulations of the three preceding Paragraphs may not apply. However, their medicaments for clinical trials shall comply with regulations of the Pharmaceutical Good Manufacturing Practice, and shall be subject to inspection by the competent health authorities. Inspections mentioned in Subparagraph 3 of Paragraph 1 shall be conducted in accordance with regulations of Article 11. Inspections mentioned in Subparagraph 4 of Paragraph 1 shall be conducted in accordance with regulations of Article 12.