Pharmaceutical Good Manufacturing Practice Regulations Article 102
Manufacturers shall establish documented procedures, work instructions, and reference materials and reference measurement procedures, as necessary, for performing servicing activities and verifying that they meet the specified requirements.Records of servicing activities carried out by the manufacturers shall be maintained.
中文原文 藥物優良製造準則第102條
製造業者應於必要時建立執行服務活動並查證該服務是否滿足規定要求之書面程序、作業指導書、參考資料與相關量測程序。
製造業者所執行之服務活動紀錄應予以維持。
製造業者所執行之服務活動紀錄應予以維持。