Pharmaceutical Good Manufacturing Practice Regulations Article 103
Manufacturers shall maintain records of the process parameters for the sterilization process which was used for each sterilization batch. Sterilization records shall be traceable to each production batch of medical devices.
中文原文 藥物優良製造準則第103條
製造業者應維持每滅菌批次之滅菌流程參數紀錄，滅菌紀錄應可追溯至醫療器材之每生產批次。