西藥製藥廠關鍵主管應具備的必要特質──從佛教「八正道」的「正見」與「正思惟」談起

The necessary qualities of character of key personnel in pharmaceutical factory — From the perspective of the “Right View” and “Adequate Thought” of the Buddhist “Noble Eightfold Path”

西藥製藥廠的作業高度仰賴於人，而人也是製藥作業中常見的風險來源。藥品的功能是在於緩解患者的病痛，甚至是要能夠幫助患者恢復健康。良好的品質管理系統是製藥廠管理藥品品質的重要工具，而品質管理系統需要有稱職的品質關鍵主管，帶領著藥廠的同仁們，共同落實與維護品質管理系統的完整性。本文主張製藥廠關鍵主管們必須具備「八正道」的「正見」與「正思惟」兩項必要特質；並輔以「親近善知識」的行動，持續地將優良製造規範GMP（Good Manufacturing Practice）落實於日常的製藥作業中。當面對偏差或異常事件時，能夠做出符合倫理的適當決定。透過「正見」與「正思惟」的養成，除了建立良好的企業文化，提升自我的管理能力外，更藉由製造優良藥品，幫助患者們「離苦」。在利他之餘，同時也是利己。

Pharmaceutical factory operations rely heavily on people, who are also the most common source of risk to such operations. The function of medicine is not only to relief the pain and illness of patients, but also to help patient to recover. A good Quality Management System is an important tool for pharmaceutical manufacturers to manage drug product quality, which needs qualified key personnel to lead staff to implement and maintain Quality Management System integrity. This article states that the pharmaceutical factory’s key personnel must have two necessary qualities of character, which are the “Right View” and “Adequate Thought” of the “Noble Eightfold Path”. Apart from “Right View” （正見） and “Adequate Thought” （正思惟） , it is also necessary to take the action of “approaching a good mentor” （Kalyāṇa-mitra 善知識） to assist GMP compliance in the daily pharmaceutical manufacturing operations. When deviations or abnormal issues occurred, we can make adequate decisions meeting ethical concerns, as necessary. Based on developing “Right View” and “Adequate Thought”, this involves not only building a good business culture and promoting self-management, but also helping patients become free from suffering by producing good quality medicine. When we help others, we benefit ourselves at the same time.