Pharmaceutical Good Manufacturing Practice Regulations Article 124
Manufacturers shall appoint a member of its own management who, irrespective of other responsibilities, shall have defined authority for the following tasks:(1) Ensuring that a quality system is established, implemented and maintained in accordance with this Chapter;(2) Reporting on the performance of the quality system to the management for review and as a basis for improvement of the quality system;(3) Ensuring the safety and effectiveness of manufactured medical devices.
中文原文 藥物優良製造準則第124條
製造業者應由管理階層中指派一人為管理代表，授權其從事下列工作：
一、確保依本章規定，建立、實施並維持品質系統。
二、向管理階層報告品質系統運作情況，以供檢討、改進品質系統。
三、確保產製醫療器材之安全及功效。
一、確保依本章規定，建立、實施並維持品質系統。
二、向管理階層報告品質系統運作情況，以供檢討、改進品質系統。
三、確保產製醫療器材之安全及功效。