Regulations of Medicament Manufacturer Inspection Article 11
Inspections mentioned in Subparagraph 3, Paragraph 1 of Article 3, of local medicament manufacturers shall be conducted by the municipal or county (city) competent health authorities jointly with the competent industry authorities; the frequency and focus of these inspections shall be as follows:(1) Once a year;(4) Inspections shall focus on the medicament manufacturer’s facilities, operational procedures of production, processing and assembly, quality control, finished products, semi-finished products, raw materials, accessory containers, packaging, labels, instructions, and factory or site safety, machinery layout and operating efficiency.
中文原文 藥物製造業者檢查辦法第11條
第三條第一項第三款之檢查，由直轄市或縣（市）衛生主管機關會同工業主管機關檢查當地之藥物製造業者；其檢查期間及重點如下：
一、每年舉行一次。
二、檢查重點除藥物製造業者之設備外，並包括其製造、加工、裝配之作業程序、品質管制及其成品、半成品、原料、配件容器、包裝、標籤、仿單與工廠或場所之安全、機器按裝排列及操作效率等。
一、每年舉行一次。
二、檢查重點除藥物製造業者之設備外，並包括其製造、加工、裝配之作業程序、品質管制及其成品、半成品、原料、配件容器、包裝、標籤、仿單與工廠或場所之安全、機器按裝排列及操作效率等。