Regulations of Medicament Manufacturer Inspection Article 3
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.
中文原文 藥物製造業者檢查辦法第3條
藥物製造業者之檢查，分類如下：
一、藥物製造業者之新設、遷移、擴建、復業或增加原料藥、劑型、加工項目、品項之檢查。
二、藥物製造業者後續追蹤管理之檢查。
三、區域例行性檢查。
四、其他檢查。
前項第一款之國產藥物製造業者，其硬體設備及衛生條件，應符合藥物製造工廠設廠標準第二編及工廠管理輔導法之規定，並由工業主管機關及直轄市或縣（市）衛生主管機關檢查之；其軟體設備及衛生條件，應符合藥物優良製造準則之規定，並由中央衛生主管機關依第四條或第六條規定檢查之。
第一項第一款之國外藥物製造業者，應符合藥物優良製造準則之規定，並由中央衛生主管機關依第五條或第七條規定檢查之。
第一項第二款之檢查，國產藥物製造業者依第八條規定辦理，國外藥物製造業者依第九條規定辦理。
經中央衛生主管機關核准為研發而製造藥物者，如未申請藥物上市許可，得不適用前三項規定。
但其臨床試驗用藥物，應符合藥物優良製造準則之規定，並由衛生主管機關檢查之。
第一項第三款之檢查，依第十一條規定辦理。
第一項第四款之檢查，依第十二條規定辦理。
一、藥物製造業者之新設、遷移、擴建、復業或增加原料藥、劑型、加工項目、品項之檢查。
二、藥物製造業者後續追蹤管理之檢查。
三、區域例行性檢查。
四、其他檢查。
前項第一款之國產藥物製造業者，其硬體設備及衛生條件，應符合藥物製造工廠設廠標準第二編及工廠管理輔導法之規定，並由工業主管機關及直轄市或縣（市）衛生主管機關檢查之；其軟體設備及衛生條件，應符合藥物優良製造準則之規定，並由中央衛生主管機關依第四條或第六條規定檢查之。
第一項第一款之國外藥物製造業者，應符合藥物優良製造準則之規定，並由中央衛生主管機關依第五條或第七條規定檢查之。
第一項第二款之檢查，國產藥物製造業者依第八條規定辦理，國外藥物製造業者依第九條規定辦理。
經中央衛生主管機關核准為研發而製造藥物者，如未申請藥物上市許可，得不適用前三項規定。
但其臨床試驗用藥物，應符合藥物優良製造準則之規定，並由衛生主管機關檢查之。
第一項第三款之檢查，依第十一條規定辦理。
第一項第四款之檢查，依第十二條規定辦理。