Pharmaceutical Good Manufacturing Practice Regulations Article 96
Manufacturers shall establish documented procedures to ensure that purchased product conforms to specified purchase requirements.The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.Manufacturers shall evaluate and select suppliers based on their ability to supply product in accordance with the manufacturers’ requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained.
中文原文 藥物優良製造準則第96條
製造業者應建立書面程序，以確保所採購之產品符合規定之採購要求。
對供應者及所採購之產品管制類型與程度，應視所採購之產品對後續產品實現或最終產品之影響而定。
製造業者應以供應者提供製造業者所規定之產品之能力為基礎，評估並選擇之。
製造業者應制定選擇、評估及重新評估之準則。
評估結果與評估所引起之任何必要措施之紀錄應予維持。
對供應者及所採購之產品管制類型與程度，應視所採購之產品對後續產品實現或最終產品之影響而定。
製造業者應以供應者提供製造業者所規定之產品之能力為基礎，評估並選擇之。
製造業者應制定選擇、評估及重新評估之準則。
評估結果與評估所引起之任何必要措施之紀錄應予維持。