Pharmaceutical Good Manufacturing Practice Regulations Article 128
Manufacturers shall adopt the following measures with respect to subcontractors:(1) Evaluating and selecting subcontractors on the basis of their ability to meet subcontract requirements including the quality system and any specific quality assurance requirements;(2) Defining the type and extent of control exercised over subcontractors depending upon the type of product, the impact of subcontracted product on the quality of final product; and, where applicable, also taking into account the quality audit reports or quality records of the previously demonstrated capability and performance of subcontractors; and(3) Establishing and maintaining quality records of subcontractors.Verification by the customer shall not be used by manufacturers as evidence for their effective quality control of subcontractors.
中文原文 藥物優良製造準則第128條
製造業者應對分包商採行下列措施：
一、根據分包商達成分包合約之能力，包括品質系統與特定之品質保證要求，評估及選擇分包商。
二、視產品類別、分包產品對最終產品品質之影響，界定對分包商之管制方式與程度；如合適時，並應參考分包商品質稽核報告或其過去展現能力與績效之品質紀錄。
三、建立並保存分包商之品質紀錄。
製造業者不得以其客戶對分包商之查證，作為其有效管制分包商品質之證明。
一、根據分包商達成分包合約之能力，包括品質系統與特定之品質保證要求，評估及選擇分包商。
二、視產品類別、分包產品對最終產品品質之影響，界定對分包商之管制方式與程度；如合適時，並應參考分包商品質稽核報告或其過去展現能力與績效之品質紀錄。
三、建立並保存分包商之品質紀錄。
製造業者不得以其客戶對分包商之查證，作為其有效管制分包商品質之證明。