Pharmaceutical Good Manufacturing Practice Regulations Article 68
Top management shall be committed to the development and implementation of the quality management system and maintain its effectiveness by providing the following evidence:(1) Communicating internally within the manufacturer on the importance of meeting customer as well as statutory and regulatory requirements concerning the safety and performance of the medical device;(2) Establishing the quality policy;(3) Establishing the quality objectives;(4) Conducting management reviews; and(5) Ensuring the availability of resources.
中文原文 藥物優良製造準則第68條
最高管理階層應建立、實施品質管理系統及維持其有效性，並提供下列事項之證據：
一、在製造業者內部傳達符合顧客及有關醫療器材安全與性能法規要求之重要性。
二、建立品質政策。
三、建立品質目標。
四、執行管理階層審查。
五、備妥所需之資源。
一、在製造業者內部傳達符合顧客及有關醫療器材安全與性能法規要求之重要性。
二、建立品質政策。
三、建立品質目標。
四、執行管理階層審查。
五、備妥所需之資源。