藥廠品質保證系統之探討-以A公司為例

Abstract

新冠病毒自2020年開始席捲全世界，奪走將近4百萬人的性命，且死亡數字有增無減。全球人民無不盼望疫苗或是解藥盡快研發上市，以解決目前的失控的疫情。雖然如此，在藥品上市之後卻有可能面對因保存不良導致藥物變質、疫苗保護力不足及未知的副作用等。儘管製藥產業在品質上的管控是非常嚴謹的，但也可能因為製程上的問題或管理上的不當，讓患者或藥品使用者承受著不必要的危險。\n\n臺灣國家品質獎的評審標準是建立在所有產業都可運用其改善管理的條件下而建構的。臺灣政府積極推動國內生技醫藥產業的發展，但經過了三十一的念頭，臺灣國家品質獎都未曾看到製藥產業業者的蹤跡。本研究透過與目前國內製藥產業業者的深度訪談瞭解到製藥公司只需要通過: 1.國際查廠標準；2.顧客的查廠；3.輸入國的藥証，即可將藥品銷售到該目標市場。\n\n在A公司目前還未達穩定營運階段，且無經營國內市場計劃的前提下，並沒有參與臺灣國家品質獎的動機。經過訪談後，高階主管表示願意依照本研究提供的建議，改善公司作業流程，並期許未來的五至十年里能夠獲頒臺灣國家品質獎這份最高榮譽。

The outbreak of COVID-19 has been spread globally since 2020. It has killed around 4 million people and the death toll is increasing unabated. The whole world is desperately hoping for vaccines or antidotes to put an end to this pandemic. However, few concerns need to be addressed before introducing such drugs, including inappropriate storage systems, poor efficacy, unknown adverse effects, and so forth. Although current quality control in place in the pharmaceutical manufacturing industry is robust, consumers may face unnecessary risks due to improper processes or management oversight.\n\nThe Taiwan National Quality Award has set up a series of evaluation criteria for management improvement which are applicable to all industries. The Taiwan government keeps encouraging and facilitating research and development in domestic biotechnology and pharmaceutical manufacturing industry, but no company from this sector has ever received such award the past 31 years since the award was established. This study went through intensive interviews with a domestic pharmaceutical manufacturer in Taiwan. It revealed that worldwide pharmaceutical manufacturers need to fulfill three standards and procedures before selling their products to the target market, namely, 1. Inspection of factory as per Pharmaceutical Inspection Co-operation Scheme (PIC/S), 2. Audit by the buyer, and 3. Drug permit license from the importing country.\n\nHowever, company A has no intention of participating in the award due to unstable operating conditions and lack of interest in domestic market. After some interviews with the top management team, company A was motivated to improve its operating procedures by following the recommendations outlined in this research. We expect the company to receive the highest honor of national quality award in the next five to ten years.