Pharmaceutical Good Manufacturing Practice Regulations Article 125
Manufacturers shall establish and maintain a file for manufacturing procedures, installation and servicing, or referring to the location(s) of this information. Their file or information shall contain documents defining the product specifications and quality system requirements (including process and quality assurance) for each type or model of medical device.
中文原文 藥物優良製造準則第125條
製造業者應建立並維持醫療器材之製造程序、安裝與維修檔案，或有關資訊之參照處所。
其檔案或資訊，應包括醫療器材每一類型或型號之產品規格、品質系統要求（含製程與品質保證）。
其檔案或資訊，應包括醫療器材每一類型或型號之產品規格、品質系統要求（含製程與品質保證）。