Pharmaceutical Good Manufacturing Practice Regulations Article 98
Manufacturers shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.Where manufacturers or their customers intend to perform verification at the suppliers’ premises, the manufacturers shall state the intended verification arrangements and method of product release in the purchasing information.Records of the above verification shall be maintained.
中文原文 藥物優良製造準則第98條
製造業者應建立與實施檢驗或其他必要活動，以確保所採購之產品符合採購要求之規定。
當製造業者或其顧客在供應者之場所實施查證時，應於採購資訊中規定查證之安排與產品放行之方法。
前項查證之紀錄應予以維持。
當製造業者或其顧客在供應者之場所實施查證時，應於採購資訊中規定查證之安排與產品放行之方法。
前項查證之紀錄應予以維持。