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台灣西藥製劑廠品質管理的倫理問題—以佛教「八正道」的義理架構為實踐路徑=Quality management ethical issues for drug manufacturers in Taiwan — A practical approach based on a Buddhist Noble Eightfold Path thought framework |
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| Author |
陳昱萍 (撰)=Jocelyn Wu-Ping Chen (compose)
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| Date | 2022 |
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| Pages | 133 |
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| Publisher | 國立中央大學 |
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| Publisher Url |
https://www.ncu.edu.tw/tw/index.html
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| Location | 桃園市, 臺灣 [Taoyuean shih, Taiwan] |
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| Content type | 博碩士論文=Thesis and Dissertation |
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| Language | 中文=Chinese |
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| Degree | doctor |
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| Institution | 國立中央大學 |
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| Department | 哲學研究所 |
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| Advisor | 孫雲平=Sun, Yun-ping |
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| Publication year | 110 |
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| Keyword | 製藥倫理=Drug manufacturing ethics; 製藥道德=Drug manufacturing morality; 八正道=Noble Eightfold Path; AP被授權人=Authorized Person; 監製藥師=Supervising Pharmacist; 優良製造規範 GMP=Good Manufacturing Practice GMP |
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| Abstract | 西藥製劑廠符合GMP的規範，對於遵守製藥倫理與藥品品質的重視，是責任也是義務。而建立優良的企業文化，應該是製劑廠主要的努力方向。藥品的品質關乎病人的權益，因此，以病人為中心，應該做為製藥的目的自身。本文提出台灣西藥製劑廠在藥品品質管理上可能發生的倫理問題，嘗試以佛教「八正道」的義理架構來解決製藥之際可能面臨的倫理問題，並以《雜阿含經》與《大智度論》所出之相關思想做為參考的依據。在製劑廠，被授權人員 (Authorized Person, AP) 負責產品的放行，對於品質系統的管理與產品品質的監督扮演著極為重要的角色。本文主張八正道中的「正見」與「正思惟」，是做為一個合格AP的必要條件。並強調只要是符合安全性、有效性的高品質藥品，確實是可以幫助病患解決身體或心理上的疾病。因此，製劑廠是一個幫助病人緩解病痛的行業，透過生產優良品質的藥品，在盡到製藥從業人員的責任與義務的同時，也幫助他人「離苦」。製劑廠在人事的管理與教育訓練上，也可以運用「三學」做為提升人員素質的重要方法。最終，期盼政府對於AP的資格認證與相關的管理辦法早日實施，協助製劑廠在品質系統的管理上，持續進步，朝著落實Best practice的方向努力。
To comply with the GMP guidance, obey drug manufacturing ethics, and to care about drug products quality are drug manufacturers’ duty and responsibility. To build a good business culture should be the major direction of effort for drug manufacturers. The quality of drugs is related to patients’ rights. Therefore, patient-centered should be the purpose of drug manufacturing itself. This thesis raises the quality management ethical issues for drug manufacturers in Taiwan. It attempts to solve possible ethical problems when producing drugs by a practical approach based on a Buddhist Noble Eightfold Path thought framework. It is also according to the thoughts as per the Saṃyukta Āgama Sutta《雜阿含經》and Mahāprajñāpāramitopadeśa《大智度論》. In the drug manufacturing factory, release products is the duty of an Authorized Person (AP). AP is playing a very crucial role for monitoring Quality System Management and drug product quality. This thesis claim that Right View (正見) and Adequate thought (正思惟) of Noble Eightfold Path are necessary principles for being a qualified AP. This thesis also emphasizes that the high-quality drugs meet the safety and efficacy conditions which can help patients to solve physical or mental illness, indeed. Therefore, the drug manufacturer is an industry which can help patients to relief their illness and pain. It also an industry which fulfills the responsibilities and obligations at the mean time also help people to “free from suffering”. With regard to the personnel management and occupational training, drug manufacturer also can apply śikṣā (三學) as the important method for enhancing the quality of personnel. At last, we look forward the government implementing regulatory of the certification of AP qualification. This is to assist drug manufacturers continuously improvement on Quality System Management, and to make effort of keep going on the way to achieve the Best practice. |
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| Table of contents | 第一章 導論 1
第一節 研究目的與建議改善現況的依據 1
第二節 研究範圍與研究方法 9
第三節 各章節主旨與摘要 13
第二章 台灣西藥製劑廠實施GMP歷程與品質管理 15
第一節 製劑廠GMP發展的歷程與GMP的定義 15
第二節 製劑廠組織與品質關鍵人員之職責 20
第三節 AP被授權人員與藥品品質的關係 28
第三章 製劑廠勞雇雙方所面臨的倫理問題 37
第一節 常見製劑廠生產與實驗作業異常的問題 37
第二節 產品品質決策面臨的倫理問題 46
第三節 企業文化與AP被授權人員的素養 54
第四章 佛教八正道的義理架構 60
第一節 何謂八正道 62
第二節 八正道與四聖諦、三學的關係 65
第三節 修持八正道的前置基礎 82
第五章 運用「八正道」解決製藥品質的倫理問題 87
第一節 八正道與製藥倫理 88
第二節 應用「八正道」於人事管理 94
第三節 建議政府對於製劑業者、AP被授權人員 100
與監製藥師之管理
第六章 結論 106
參考文獻 111 |
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| Hits | 62 |
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| Created date | 2023.05.29 |
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| Modified date | 2023.05.29 |
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