Regulations of Medicament Manufacturer Inspection Article 4
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.
中文原文 藥物製造業者檢查辦法第4條
新設、遷移、擴建、復業或增加原料藥、劑型、加工項目之國產藥品製造業者，應繳納費用，並填具藥品優良製造評鑑申請表及檢附下列資料，向中央衛生主管機關申請檢查：
一、通過硬體檢查之證明文件或工廠登記證明文件。
二、填具製藥工廠基本資料查核表，並依查核表所載事項檢附工廠基本資料（SiteMasterFile，以下簡稱SMF）。
前項檢查，中央衛生主管機關得會同直轄市或縣（市）衛生主管機關赴廠檢查之。
一、通過硬體檢查之證明文件或工廠登記證明文件。
二、填具製藥工廠基本資料查核表，並依查核表所載事項檢附工廠基本資料（SiteMasterFile，以下簡稱SMF）。
前項檢查，中央衛生主管機關得會同直轄市或縣（市）衛生主管機關赴廠檢查之。