Pharmaceutical Good Manufacturing Practice Regulations Article 73
Top management shall establish a documented procedure to ensure that responsibilities and authorities are defined, documented and communicated internally within the manufacturer.Top management shall establish the interrelation of all personnel who manage, perform and verify work affecting quality, and shall ensure the independence and authority necessary to perform these tasks.Manufacturers shall nominate responsible persons for activities related to monitoring experience from the post-production stage and reporting adverse events.
中文原文 藥物優良製造準則第73條
最高管理階層應以書面規定並溝通內部之責任與職權。
最高管理階層應針對擔任會影響品質之管理、執行與查證工作之人員，建立其相互關係，並確保所必要之獨立性與職權。
製造業者應任命負責監管與監控從生產後階段獲取經驗及不符合事件報告等活動之特別人員。
最高管理階層應針對擔任會影響品質之管理、執行與查證工作之人員，建立其相互關係，並確保所必要之獨立性與職權。
製造業者應任命負責監管與監控從生產後階段獲取經驗及不符合事件報告等活動之特別人員。