Loading...
|
Please use this identifier to cite or link to this item:
https://nccur.lib.nccu.edu.tw/handle/140.119/137187
|
| Title: | 藥廠品質保證系統之探討-以A公司為例
Quality Assurance System in Pharmaceutical Industry- A Case Study of A Company |
| Authors: | 蘇雯琪
Siow, Woon Chyi |
| Contributors: | 李易諭
Li, Yi-Yu
蘇雯琪
Siow, Woon Chyi |
| Keywords: | 全面品質管理
國家品質獎架構
品質保證系統
臺灣製藥產業
Total Quality Management
Framework of National Quality Award
Quality Assurance Systems
Pharmaceutical Manufacturing Industry in Taiwan |
| Date: | 2021 |
| Issue Date: | 2021-09-02 18:21:51 (UTC+8) |
| 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。
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。
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.
The 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.
However, 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. |
| Reference: | 中文
《台灣醫學》2003年7卷3期。《老年人之用藥原則》。國立成功大學醫學院附設醫院家庭醫學部，黃盈翔 盧豐華。Retrieved 01 July 2021, from http://dr.hosp.ncku.edu.tw/upload/basic_knowledge_download/27/7ee476f79c4b1bf79209b116fffd5863a62ddb00a24986fc21a241a23d99c439.pdf
《生技健康產業上市櫃審議應注意事項（含以科技事業身分申請者）─ 以生技醫療製藥產業為例》，作者：許淑敏，KPMG安侯建業審計部執業會計師。Retrieved 01 July 2021, from https://home.kpmg/tw/zh/home/insights/2018/08/tw-kpmg-healthcare-12-courses-ch7.html
《藥師週刊電子報》。《老人用藥探討：老化現象導致的藥效學變化》。《康大學報》。Retrieved 01 July 2021, from https://www.taiwan-pharma.org.tw/weekly/1575/1575-5-1.htm
Cheryl and ein（2014，November 14）。
《藥品開發上市攻防戰-專利法規》。股感知識庫。Retrieved 10 May 2021, from https://www.stockfeel.com.tw/%E5%B0%88%E5%88%A9%E6%B3%95%E8%A6%8F/#:~:text=%E5%8F%B0%E7%81%A3%E5%B0%8D%E5%B0%88%E5%88%A9%E8%97%A5%E5%8F%8A%E5%AD%B8%E5%90%8D%E8%97%A5%E7%9A%84%E4%BF%9D%E8%AD%B7&text=%E7%99%BC%E6%98%8E%E5%B0%88%E5%88%A9%E7%9A%84%E4%BF%9D%E8%AD%B7%E6%9C%9F%E9%99%90,%E8%97%A5%E7%9A%84%E7%94%B3%E8%AB%8B%E6%9F%A5%E9%A9%97%E7%99%BB%E8%A8%98%E3%80%82&text=%E5%A6%82%E6%AD%A4%E4%B8%80%E4%BE%86%E8%A8%88%E7%AE%97%E5%B0%88%E5%88%A9,%E5%B0%88%E5%88%A9%E5%85%AC%E5%91%8A%E6%97%A5%E9%96%8B%E5%A7%8B%E8%A8%88%E7%AE%97%E3%80%82
MBA智庫百科。《什麼是關鍵績效指標？》。Retrieved 6 June 2021, from https://wiki.mbalib.com/wiki/KPI
MBA智庫百科。什麼是生產者剩餘？Retrieved 11 April 2021, from https://wiki.mbalib.com/zh-tw/%E7%94%9F%E4%BA%A7%E8%80%85%E5%89%A9%E4%BD%99
MBA智庫百科。什麼是消費者剩餘？Retrieved 11 April 2021, from
https://wiki.mbalib.com/zh-tw/%E6%B6%88%E8%B4%B9%E8%80%85%E5%89%A9%E4%BD%99
MBA智庫百科。什麼是BCG矩陣？Retrieved 11 June 2021, from https://wiki.mbalib.com/zh-tw/%E6%B6%88%E8%B4%B9%E8%80%85%E5%89%A9%E4%BD%99
中華民國內政部統計處（2020）。《內政統計主題專區》。Retrieved 12 May 2021, from https://www.moi.gov.tw/News_Content_StatisticTheme.aspx?n=2441&sms=10306&s=83728
世界衛生組織。《2020年 世界衛生統計 · 針對可持續發展目標檢測衛生狀況》。Retrieved 12 May 2021, from http://dr.hosp.ncku.edu.tw/upload/basic_knowledge_download/27/7ee476f79c4b1bf79209b116fffd5863a62ddb00a24986fc21a241a23d99c439.pdf
台大醫院健康電子報。《老人用藥安全》。Retrieved 01 July 2021, from https://epaper.ntuh.gov.tw/health/201608/project_3.html
全國法規資料庫。《生技新藥產業發展條例》。Retrieved 19 May 2021, from https://law.moj.gov.tw/LawClass/LawAll.aspx?pcode=J0040046
全球經濟論壇。《2020全球競爭力報告》。Retrieved 19 May 2021, from http://www3.weforum.org/docs/WEF_TheGlobalCompetitivenessReport2020.pdf
行政院。重要政策與計劃。 《加速生技醫療產業創新—打造臺灣成為國際生醫創新研發樞紐》。 Retrieved 10 May 2021 from https://www.ey.gov.tw/Page/5A8A0CB5B41DA11E/fea217e2-81da-46bc-9fe5-55cfe66b53a0#:~:text=%E4%B8%89%E3%80%81%20%E8%87%BA%E7%81%A3%E7%94%9F%E9%86%AB%E5%89%B5%E6%96%B0,%E8%87%B3109%E5%B9%B47%E6%9C%88%E5%BA%95)&text=%E6%AF%8F%E5%B9%B4%E5%B8%B6%E5%8B%95%E7%94%9F%E9%86%AB%E7%94%A2%E6%A5%AD,%E8%B6%85%E9%81%8E2%E5%8D%83%E5%84%84%E5%85%83%E3%80%82&text=108%E5%B9%B4%E5%90%AB%E5%81%A5%E5%BA%B7%E7%A6%8F%E7%A5%89,%E5%85%83%EF%BC%8C%E6%95%B4%E9%AB%94%E6%88%90%E9%95%B78.7%25%E3%80%82&text=%E8%87%BA%E7%81%A3%E8%88%88%E6%AB%83%E3%80%81%E4%B8%8A%E6%AB%83,%E5%B7%B2%E7%AA%81%E7%A0%B41%E5%85%86%E5%85%83%E3%80%82
行政院新聞傳播處。發佈於109-10-28。《加速生技醫療產業創新—打造臺灣成為國際生醫創新研發樞紐》。Retrieved 19 May 2021, from https://law.moj.gov.tw/LawClass/LawAll.aspx?pcode=J0040046
每日頭條。《50年代的美國，街頭路邊到處都是汽車》。Retrieved 01 July 2021, from https://kknews.cc/zh-tw/history/zba586l.html
科達製藥股份有限公司官方網站Koda.com.tw. 2021. 科達製藥股份有限公司. Retrieved 21 April 2021, from http://www.koda.com.tw/about01.aspx
钜亨網。《初學者如何投資生技？新藥篇》。Retrieved 01 July 2021, from https://topics.cnyes.com/biotech01/
國家發展委員會。（2020年8月）。《中華民國人口推估（2020至2070年）》。Retrieved 29 June 2021, from https://pop-proj.ndc.gov.tw/upload/download/%E4%B8%AD%E8%8F%AF%E6%B0%91%E5%9C%8B%E4%BA%BA%E5%8F%A3%E6%8E%A8%E4%BC%B0(2020%E8%87%B32070%E5%B9%B4)%E5%A0%B1%E5%91%8A.pdf
張世奇（2020, March 31）。中華徵信所。《Top 5000產業風雲-製藥業：「疫情籠罩下 製藥業的資源最佳化」》。Retrieved 11 May 2021, from http://www.credit.com.tw/NewCreditOnline/Epaper/IndustrialSubjectContent.aspx?sn=281&unit=485#:~:text=%E5%8F%A6%E6%93%9A%E7%B6%93%E6%BF%9F%E9%83%A8%E6%9C%80%E6%96%B0,9.0%25%EF%BC%8C%E5%B8%82%E5%A0%B4%E9%9C%80%E6%B1%82%E5%B9%B3%E7%A9%A9%E3%80%82
張益紳 & 舒世明（2019, January 31）。勤業眾信風險管理諮詢(股)公司。《客戶關係管理(CRM)對台灣化工集團帶來的改變與轉型》。Retrieved 9 April 2021, from https://www2.deloitte.com/tw/tc/pages/risk/articles/eri-chemical-report.html
張豈毓（2019）。《醫藥序列化導入自動化瓶裝包裝與出貨產線管理系統-以個案T藥廠為例》。國立中興大學資訊管理學系所碩士學位論文。
產業價值鏈鏈資訊平台。《製藥產業鏈簡介》。Retrieved 01 July 2021, from https://ic.tpex.org.tw/introduce.php?ic=C100
陳、蔡&趙（2018）。《社區老年人用藥安全之檢測與評估》。《康大學報》。Retrieved 01 July 2021, from https://daa.ukn.edu.tw/ezfiles/6/1006/img/1340/122316143.pdf
陳韋均（2016）。《以價值溪流圖改善製藥廠流程》。逢甲大學工業工程與系統管理學系學位論文。
傅高義 (1979)。《日本第一：對美國的啟示》。
彭嚴燕（1999, June 30）。《從2004~2006年全球藥品使用趨勢分析全球疾病與用藥發展》，臨床醫學·The Journal of Taiwan Pharmacy，第25卷，第2期。Retrieved 10 May 2021, from http://jtp.taiwan-pharma.org.tw/99/030-039.html
辜宏義（1993）。《品質成本制度之規劃與設計─國內製藥廠之個案研究》。國立臺灣大學會計學研究所碩士學位論文。
經理人新書快報。《工作輪調》。Retrieved 9 June 2021, from https://www.managertoday.com.tw/english/vocabulary/view/376
經濟部工業局《108年企業經營品質躍升計劃（功能別說明會）1080212V9》https://www.google.com/url?sa=i&url=https%3A%2F%2Fwww.moeaidb.gov.tw%2Fexternal%2Fctlr%3FPRO%3Dfilepath.DownloadFile%26f%3Dproject%26t%3Df%26id%3D508&psig=AOvVaw1MUHGzm_4_dXADgmsZDoKA&ust=1617350198547000&source=images&cd=vfe&ved=2ahUKEwj86uGRydzvAhUDfN4KHcUBCxQQr4kDegQIARBF
經濟部生技醫療產業發展推動小組。《產業範疇》。Retrieved 10 May 2021, from https://biopharm.org.tw/information_content.php?li=1
經濟部生技醫療產業發展推動小組。《臺灣2021生技醫療產業簡介》。Retrieved 10 May 2021 from https://www.biopharm.org.tw/images/2020/1091215.pdf%20
經濟部生技醫藥產業發展推動小組。生醫情報Biopharm.org.tw. 。Retrieved 10 May 2021 from https://biopharm.org.tw/information_content.php?li=1
精準生技股份有限公司。生技新知。《全球藥品市場及產業趨勢》。Retrieved 10 May 2021 from https://precisionthera.com/%e5%85%a8%e7%90%83%e8%97%a5%e5%93%81%e5%b8%82%e5%a0%b4%e5%8f%8a%e7%94%a2%e6%a5%ad%e8%b6%a8%e5%8b%a2/
臺灣生技網。《申請中國保健食品之配方、配方依據及研發報告》。Retrieved 8 June 2021, from http://www.taiwanbio.com.tw/property_detail.php?sno_property=87
臺灣行政院國家發展委員會。《國家發展委員會組織法》。Retrieved 11 May 2021, from https://www.ndc.gov.tw/cp.aspx?n=7DEC7150E6BAD606&s=5941D5DCC3DD7DDA
臺灣國家發展委員會人口推估查詢系統。常用資料查詢。《零歲平均餘命》。Retrieved 29 June 2021, from
https://pop-proj.ndc.gov.tw/dataSearch3.aspx?r=2&uid=2104&pid=59
臺灣衛生福利部。108-02-01公告《健保署公告108年藥價調整，平均調幅3.5%》。Retrieved 12 May 2021, from https://www.mohw.gov.tw/cp-4260-46381-1.html#:~:text=%E4%B8%AD%E5%A4%AE%E5%81%A5%E4%BF%9D%E7%BD%B2%E6%96%BC1,4%E6%9C%881%E6%97%A5%E7%94%9F%E6%95%88%E3%80%82
歐洲品質管理基金會。簡介。Retrieved 11 April 2021, from https://www.efqm.org/about
潘忠煜 & 黃義清 (2013, December 31)。《國家品質獎對企業經營績效影響之研究》. 品質學報，20卷6期。Retrieved 9 April 2021, from https://www.airitilibrary.com/Publication/alDetailedMesh?docid=10220690-201312-201401060031-201401060031-609-626
衛生福利部食品藥物管理署。2021。機關介紹。使命、願景與目標。Retrieved 4 June 2021, from https://www.fda.gov.tw/TC/siteContent.aspx?sid=75
聯合國經濟及社會理事會，《世界人口老化：2019》（The World Population Ageing 2019）。Retrieved 11 May 2021, from https://www.un.org/en/development/desa/population/publications/pdf/ageing/WorldPopulationAgeing2019-Highlights.pdf
關鍵評論《從實驗到上市，一款藥物的開發可以耗費多少青春與成本？》。Retrieved 1 July 2021 from https://www.thenewslens.com/article/95507
龔莛茜（2011）。《臺灣國家品質獎與公司市場價值之實證研究》。清華大學工業工程與工程管理學系學位論文。
二、 英文
Albert, N. Link & John, T. Scott (2011, December 16). Economic Evaluation of the Baldrige Performance Excellence Program. Retrieved March 22, 2021, from https://www.nist.gov/system/files/documents/2017/05/09/report11-2.pdf
Deming, W. E. (1982). Deming’s 14 Points for the Transformation of Management. In Out of the Crisis (pp. 23-24). Cambridge, Massachusetts: Massachusetts Institute of Technology, Center for Advanced Educational Services.
James, R. Evans, & Eric, P. Jack (2003). Validating Key Results Linkages in the Baldrige Performance Excellence Model. Quality Management Journal, Volume 10, Issue 2, Page 7-24. Retrieved March 23, 2021, from https://www.tandfonline.com/doi/abs/10.1080/10686967.2003.11919060
Kothari, C. (2004). Research Methodology: Methods and Techniques (Second Revised Edition ed.). New Age International Publishers.
National Institute of Standards and Technology, US Department of Commerce (2019, November 16). History. Retrieved March 01, 2021, from https://www.nist.gov/baldrige/how-baldrige-works/about-baldrige/history#:~:text=In%20the%20mid%2D1980s%2C%20U.S.,%2Dexpanding%2C%20demanding%20global%20market.&text=The%20goal%20of%20the%20Malcolm,the%20competitiveness%20of%20U.S.%20businesses.
Population Reference Bureau (2020). World Population Data Sheet. Retrieved 12 May 2021, from https://interactives.prb.org/2020-wpds/asia/#east-asia
Robert Handfield, Soumen Ghosh & Stanley Fawcett (1998). Quality-Driven Change and its Effects on Financial Performance. Quality Management Journal, Volume 5, Issue 3, Page 13-30. Retrieved March 23, 2021, from https://www.tandfonline.com/doi/abs/10.1080/10686967.1997.11918813
Tapemark. Pharmaceutical CDMOS. Contract Development and Manufacturing Organizations. Chapter 1: What is a CDMO. Retrieved 11 May 2021, from https://www.tapemark.com/pharmaceutical-cdmos
U.S. Food and Drug Administration. 2021. What We Do. Retrieved 4 June 2021, from https://www.fda.gov/about-fda/what-we-do
Walgren, D. (1987, August 20). Text - H.R.812 - 100th CONGRESS (1987-1988): Malcolm Baldrige National quality Improvement act of 1987. Retrieved March 02, 2021, from https://www.congress.gov/bill/100th-congress/house-bill/812/text/pl?overview=closed |
| Description: | 碩士
國立政治大學
企業管理研究所(MBA學位學程)
108363107 |
| Source URI: | http://thesis.lib.nccu.edu.tw/record/#G0108363107 |
| Data Type: | thesis |
| DOI: | 10.6814/NCCU202101298 |
| Appears in Collections: | [企業管理研究所（MBA學位學程）] 學位論文
|
Files in This Item:
| File |
Description |
Size | Format | |
|---|
| 310701.pdf | | 2685Kb | Adobe PDF2 | 28 | View/Open |
|
All items in 政大典藏 are protected by copyright, with all rights reserved.
|
