臺灣博碩士論文加值系統

本研究之目的為了解2011~2017年「台灣中藥廠從業人員GMP作業之教育訓練」課程，對學員之幫助度及對未來課程需求之規劃，以問卷方式透過調查及資料統計分析，將結果作為未來人才培訓之參考。共發放240份，有效回收率85.0%。以Excel 2017及SPSS 12版套裝軟體進行描述性統計分析、獨立樣本t檢定、單因子變異數分析。
綜合分析結果 (1)受訪者大部分為基層員工，占41.2%；在辦理之教育訓練課程有55位受訪者未上過課，占65.5%為基層員工，顯見藥廠基層員工流動率很高、廠內對於員工基本教育訓練仍不足，新進人員被安排接受教育訓練機會少。(2)有77.5%受訪者認為外部教育訓練不足夠，40.2%認為主要原因是開課單位太少，顯見中藥廠從業人員之教育訓練應持續辦理，政府應多與學校、法人機構、相關政府部門、公協會宣導辦理人才培訓課程，以促進整體產業人才能力之提升。(3)有30.4%受訪者認為每年應該至少有24小時的教育訓練課程，有42.7%認為理想上課人數是30-60人，以小班制實務教學方式辦理。(4)十四大項課程中，沒有上過課的人數百分比為46.6%~73.5%；又以1.品保及品質系統常見缺失2.GMP後續查廠之查核重點兩項課程平均幫助度分數最高，為4.36分。顯示中藥廠從業人員受益僅約占50.0%左右。因衛生福利部並沒有明確政策宣示中藥廠GMP製造法規要提升與國際接軌，業者持觀望態度，以先了解政策趨勢為首要，加上業界持反對態度，藥廠亦無實際執行提升各項品質系統之壓力，故受益不大。(5)因應國際趨勢，綜合所需之教育訓練課程項目，將針對國內現行法規政令、文件管理系統、品質管制系統、品質管理系統、確效作業、及實作課程做為未來課程規劃之參考。

The target of this study was to understand the degree of help to the trainees in the “Education and Training of Practitioners for GMP Operations in Taiwanese Chinese Medicine” conducted during 2011 and 2017, and to provide as a reference for future program planning. With the questionnaires for statistical analysis of survey and information, the results will be provided as a reference for future personnel training. A total of 240 questionnaires were released, the effective recovery rate is 85%. The software applications Excel 2017 and SPSS 12 edition were applied for descriptive statistical analysis,　Independent-Sample t test, and one-way analysis of variance.
The results of this study are summarized as follows:(1) Most of the respondents were junior staff, accounting for 41.2%; 55 of which had not attended the education and training courses conducted in 2011-2017, accounting for 65.5% of the junior staff. It is obvious that the turnover rate of junior staff in pharmaceutical companies was high, still insufficient for the basic education and training of employees in the factories, and the opportunities to receive education and training were few for entry level employees. (2) 77.5% of the respondents believed that external education and training was insufficient. 40.2% of which believed that the main reason was insufficiency of training units. It was obvious that the education and training of the practitioners of Chinese medicine companies should be carried out continuously, and that the government should promote and conduct more training courses with schools, foundations, relevant government departments, and public associations to implement personnel training programs, so as to enhance the professional ability of overall industry.(3) 30.4% of the respondents believed that there should be at least 24 hours of education and training programs per annum; and 42.7% of them believed that 30 to 60 should be the ideal number of attendance; and a small-class practical training should be implemented.(4) For the respondents participating in the 14 major programs of "Education and Training of Practitioners for GMP Operations in Taiwanese Chinese Medicine" conducted during 2011 and 2017, the percentage of persons who had not attended training courses was 46.6% to 73.5%, and the courses that helped the respondents the most was 1.The quality assurance and quality system are often missing.2.The GMP follow-up inspection of the key points of the two courses has the highest average help score of 4.36 points.signifying that the training courses of Chinese medicine practitioners for GMP operations benefited only about 50%. Therefore, during that time, the Ministry of Health and Welfare did not clearly declare that the GMP manufacturing regulations of Chinese medicine companies should be updated and in line with the global standards; so the companies was sitting on the fence. For them, it was their priority to comprehend the trend of government policies; furthermore, due to the opposition from the industry, the pharmaceutical companies also have no pressure to conduct improvement for each of their quality systems, so the benefits were not great. (5) To meet international trends, comprehensive education and training programs are required, such as the existing domestic policies & decrees, document management system, quality control system, quality management system, validation operation, and practical programs are focused as the references for future program planning.

中文摘要 …………………………………………………………… Ⅰ
英文摘要 …………………………………………………………… Ⅱ
誌　　謝 …………………………………………………………… Ⅳ
目　　錄 …………………………………………………………… Ⅴ
第一章 前言 ………………………………………………………. 1
　第一節　研究動機與背景 ……………………………………… 1
第二節　研究目的 ……………………………………………… 7
第二章 文獻探討 …………………………………………………. 9
第一節　我國中藥製劑之定義、市場及GMP現況 …… 9
第二節 製藥業就業情形及人才需求探討 ………………11
第三節 教育訓練需求探討 ……………………………………. 15
第四節 教育訓練實施程序 ……………………………………. 17
第五節 藥廠員工培訓管理探討 ………………………………. 19
第六節 教育訓練需求之相關研究 …………………………….22
第三章 研究方法 …………………………………………………. 29
第一節 研究設計與方法 ………………………………………. 29
第二節 問卷內容 ………………………………………………. 32
第四章 結果與討論 ……………………………………………….. 36
第一節 問卷預試驗結果 ……………………………………….. 36
第二節 問卷分析結果 ………………………………………….. 36
第三節 問卷推論性統計分析結果 …………………………….74
第五章 結論 ………………………………………………………. 87
第一節 結論 …………………………………………………… 87
第二節 研究限制 ……………………………………………… 92
參考文獻 …………………………………………………………… 94
附錄一 問卷調查表 ……………………………………………….. 98
附錄二 專家學經歷………………………………………………….. 102

1.中華民國勞動部。行業職業就業指南。台北:勞動部; 2019: 1-16。
2.譚伯群，蔡宗義。台灣中藥製造業關鍵價值因素之研究。崑山科技大學碩士論文。2006。
3.陳再晉。臺灣中藥製劑尋寶導覽-臺灣中藥GMP實施概況暨藥廠簡介。台北:行政院衛生署中醫藥委員會; 2006: 10-19。
4.衛生福利部中醫藥司。「中藥優良製造確效作業基準」及實施時程。
5.王基山。台灣藥廠違規態樣之分析研究。大仁科技大學藥學系製藥科技研究所碩士學位論文。2016。
6.衛生福利部。2025衛生福利政策白皮書暨原住民族專章（電子版第一版）。台北:衛生福利部; 2016: 151-154。
7.李威著。藥品優良製造規範（GMP）中藥部分解說及缺失說明。行政院衛生署中醫藥委員會。強化中藥製程安全與建立研發平台及中醫藥產業科技人才培訓中心委託研究計畫。2011。
8.李威著。中藥GMP實務人員法規制度培訓計畫。行政院衛生署中醫藥委員會。建立中草藥用藥安全資訊中心及人才培訓中心委託研究計畫。 2012。
9.李威著。中藥GMP實務及PIC/S GMP法規教育訓練。行政院衛生署中醫藥委員會。落實中藥製劑（材）品質管制及人才培訓中心委託研究計畫。 2013。
10.陳威仁。中藥GMP實務及PIC/S GMP法規教育訓練。衛生福利部。提升中藥製藥環境與品質計畫二。2015。
11.陳威仁。中藥GMP缺失解說及製藥產業人員訓練。衛生福利部。提升中藥製藥環境與品質計畫二。2016。
12.李威著。GMP相關法規編修暨產業輔導。衛生福利部。105年度GMP中藥廠產業精進計畫計畫二。2016。
13.李威著。GMP相關法規編修暨產業輔導。衛生福利部。106年度GMP中藥廠產業精進計畫計畫二。2017。
14.吳忠勳。2018生技產業白皮書。台北:經濟部工業局; 2018: 66-67, 304-307, 354-357。
15.劉祖惠。2017醫藥產業年鑑。台北:財團法人生物技術開發中心; 2017: 224-358。
16.胡肇東。影響台灣中草藥業國際競爭力之因素。大同大學事業經營研究所碩士論文。2007。
17.陳心懿，謝明德，郭芳妏。個人因素與職能訓練需求之探討。中華管理評論國際學報。2011; 14(3): 1-21。
18.陳勝吉。個人特質、課程設計及工作環境與訓練移轉認知關係之研究¬-以臺灣警察專科學校97年巡佐班為例。國立政治大學社會科學學院行政管理碩士學程第七屆碩士論文。2008。
19.Hui-Po Wang, Chun-Li Wang. Risk undermined in the bilateral pharmaceutical regulatory system in Taiwan. Journal of food and drug analysis. 2018; 26:3-11.
20.黃怡超。中藥廠實施PIC/S GMP之推動規範。中醫藥年報。台北:衛生福利部; 2015: 47-78。
21.林宜信。中藥執行cGMP之可行性。中醫藥年報。台北:行政院衛生署中醫藥委員會; 2005: 147-164。
22.黃怡超。中藥廠稽查人員培訓。中醫藥年報。台北:衛生福利部; 2015: 106-135。
23.黃怡超。中藥廠實施PIC/S GMP輔導及稽查人員訓練。中醫藥年報。台北:衛生福利部; 2016: 396-429。
24.Hae Sun Suh, Hye-Young Kang. Educational demands of pharmacists working in the pharmaceutical industry under the reformed 6-year pharmacy education system in Korea. Pharmacy Education. 2014; 14(1): 76-80.
25.李志恆, 馮齡儀。我國藥學教育改革:（一）現況與問題。藥學雜誌。2015; 31(2): 2-5。
26.田逸星。台灣中藥製造業經營策略之探討。國立成功大學工業管理科學研究所碩士論文。2002。
27.陳映樺。21世紀藥品GMP新趨勢與挑戰。藥物食品簡訊月刊。2007; 317: 1-10。
28.衛生福利部食品藥物管理署。西藥藥品優良製造規範（第一部、附則）PIC/S: Guide to Good Manufacturing Practice for Medicinal Products(Part Ⅰ、Annexes)PE009-13(1 January 2017) PIC/S January 2017。台北:衛生福利部; 2017。
29.Sudhanshu Bala Singh, R. S. Dhalla. Effect of Total Quality Management on Performance of Indian Pharmaceutical Industries. Proceedings of the 2010 International Conference on Industrial Engineering and Operation Management Dhaka Bangladesh. 2010; 9-10.
30.James E. Carter. Quality Policies-Key to GMP Compliance. Pharmaceutical Technology. 1998; 1-5.
31.Vivian Bringslimark. If Training Is So Easy, Why Isn’t Everyone in Compliance? Biopharm International. 2004; 1-6.
32.蘇柏全。訓練資源之e化管理。國家文官學院 T&D飛訊。2013; 159: 1-20。
33.Goldstein. Training and Development in Organizations, Ann Arbor, MI: Proquest Information and Learning. 1989.
34.方世榮（譯）（2001），人力資源管理（Gary Dessler）。台北: 華泰; 2001。
35.許南雄。人事行政學。台北: 商鼎文化出版社; 2016。
36.張添洲。人力資源-組織、管理、發展。台北: 五南出版社; 1999。
37.Lazear, E.P. Personnel Economics for Managers, N.Y: John Wiley & Son, Inc.1998.
38.A WHO guide to good manufacturing practice（GMP）requirements Part 3:Training. 6.Administrating a training program me. 2006; 71-81. Printed by the WHO Document Production Services, Geneva, Switzerland. 2006。
39.香港生產力促進局。製藥基本標準操作程序（SOP）的參考範本。香港:香港中藥學會香港生產力促進局聯合出版; 2016。
40.Deeksha R Pai, Krishnananda Kamath K, E V S Subramanyam, A R Shabaraya, Personnel Training for Pharmaceutical Industry, International Journal of Pharmaceutical Quality Assurance. 2016; 7(3); 55-61.
41.陳炳義，葉修如，陳瑞祥。動物用生物藥品cGMP推廣訓練之研究。農業推廣體系及人力資源之研究。2000; 105-109。
42.陳炳義，葉修如，陳瑞祥。動物用藥生產系統提升現行藥品優良製造規範之職能調查及訓練之研究。2001; 98-102。
43.陳美玲。衛生福利部。105年度「GMP中藥廠產業精進計畫」分項1:中藥廠GMP種子師資專業知能提升暨稽查品質系統建立與人員訓練。2016。
44.吳明隆。統計應用學習實務:問卷分析與應用統計。台北: 易習圖書; 2007。
45.Nunnally, J. C. Psychometric Theory (2nd ed.). New York: McGraw-Hill; 1978.