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研究生:張志鍠
研究生(外文):Chih-Huang Chang
論文名稱:可驗證之製藥業電腦化系統確效
論文名稱(外文):Verifiable Computerized System Validation for the Pharmaceutical Industry
指導教授:朱正忠朱正忠引用關係
指導教授(外文):C.W. Chu
學位類別:碩士
校院名稱:東海大學
系所名稱:資訊工程與科學系碩士在職專班
學門:工程學門
學類:電資工程學類
論文種類:學術論文
論文出版年:2009
畢業學年度:97
語文別:中文
論文頁數:55
中文關鍵詞: 藥品GMP 確效 電腦化系統確效 存取管控 可追溯性 系統發展生命週期 驗證
外文關鍵詞: Good Manufacture Practice GMP Validation Computerized System Validation CSV Access Control Traceability System Devel
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台灣藥品GMP自1982年實施至今;前後已近30年歷史。其間;為因應全球化趨勢及達成與世界接軌的目的;政府部門不斷參考國際先進製藥規範;引進國內輔導實施;民間製藥業界也投入龐大資源更新設備及吸取最新管理手法。幾經變革;台灣藥品製造及品質已與國際趨於一致。迄今;台灣163家製藥廠已完成第三階段確效評鑑;藥品製造管理水準已邁入世界先進國家之列。
在施行確效的過程中;為達成政府限期完成電腦化系統確效的目標;國內藥廠不惜投入大量硬體設備及軟體資源,但礙於台灣軟體產業特性及藥廠經營規模;目前藥廠的電腦化系統中仍普遍存著:人員的存取管控、資料的可追溯性...等資訊安全議題的潛在風險。
本論文以已通過全面確效的藥廠電腦化系統建置經驗為例;提供如何兼顧藥廠嚴格的生產驗證程序;又能依循系統發展生命週期模型;使電腦化系統過程能逐步驗證;以確保電腦化過程中資料的安全性及自動化設備所製造出藥品的品質。
It has been nearly 30 years since the adoption of Taiwanese Good Manufacture Practice(GMP) in 1982. Within this period, in order to achieve the objective of
connecting to the world standard and meeting the global trend, the Taiwanese government has been following the international medicinal production guideline and put into practice domestically. The local medicinal industry has also invested a great deal of resources in replacing hardware facilities and learning the latest management practices. After having several runs of improvement, Taiwanese medicinal product manufacturing and quality level have been in line with the international standards. There are 163 Taiwanese medicinal product manufacturers who have finished the 3rd stage validation qualification and their quality level of manufacturing management has been among the same level as most of the developed countries.
During the process of adopting the validation practices, in order to achieve the goal of Computerized System Validation(CSV) in the scheduled deadline requested by the government, Taiwanese Pharmaceutical companies have invested a great deal of resources in hardware equipments and software technologies. However, there still exist in these CSVs some potential risks involving the information safety issues such as the loophole of data access control and traceability. These problems are caused by the specific characteristics of Taiwan software engineering industry and the business scale of pharmaceutical companies.
This thesis use a verified pharmaceutical CSV system as an example to demonstrate how to validate the stringent manufacturing process control at the same time stick to the requirement of software development life cycle model. By doing that, the development and operational processes for the computerized systems can be fully verified to ensure the data safety in the computerization processes and the quality of the automated-produced medicinal products.
摘要------------------------------------------------------------- ii
Abstract---------------------------------------------------------iii
誌謝--------------------------------------------------------------v
目次--------------------------------------------------------------vi
圖目錄------------------------------------------------------------ix
表目錄------------------------------------------------------------xi
第 1 章 緒論-------------------------------------------------------1
1.1 研究動機--------------------------------------------------1
1,2 研究目的--------------------------------------------------2
1.3 論文章節概要-----------------------------------------------3
第 2 章 背景智識與理論探討-------------------------------------------5
2.1 名詞解釋及說明---------------------------------------------5
2.1.1 GMP---------------------------------------------------------5
2.1.2 cGMP -------------------------------------------------------6
2.1.3 GAMP-----------------------------------------------7
2.1.4 FDA 21 CFR part 11 --------------------------------8
2.1.5 PIC/S -----------------------------------------------------10
2.1.6 3Q(IQ;OQ;PQ)-----------------------------------------------12
2.2 理論探討------------------------------------------------------12
2.2.1 System Development Life Cycle (SDLC)-----------------------12
2.2.2製藥業之Validation Life Cycle--------------------------------14
2.2.3 Computer/Computerized System Validation--------------------16
2.2.4 CMMI簡介 --------------------------------------------------21
2.2.5 VER&VAL----------------------------------------------------27
2.2.6 製藥業可驗證的SDLC V-Model-----------------------------------30
第 3 章 個案探討---------------------------------------------------33
3.1 個案困境及說明--------------------------------------------33
3.2 個案實施過程----------------------------------------------33
3.3 個案目標及執行方法----------------------------------------35
3.3.1 個案目標 ------------------------------------------35
3.3.2 執行方法 ---------------------------------------------------35
3.4 施行成果-------------------------------------------------37
第 4 章 實作規劃 --------------------------------------------------40
4.1存取控管(Access Control)系統需求及實作方法------------------40
4.1.1 Windows登入管制------------------------------------41
4.1.2 SQL server 登入設定--------------------------------41
4.1.3使用端執行環境確認-----------------------------------41
4.1.4使用端使用者身份確認---------------------------------42
4.1.5使用者授權展開---------------------------------------43
4.1.6異常訊息記錄----------------------------------------44
4.2可追溯性(Traceability)系統需求及實作方法--------------------45
4.2.1請購作業--------------------------------------------46
4.2.2採購作業--------------------------------------------47
4.2.3收料作業--------------------------------------------47
4.2.4檢驗作業--------------------------------------------48
4.2.5原物料入庫作業---------------------------------------48
4.2.6生產計畫與發、領料作業--------------------------------49
4.2.7製程管理與成品繳庫-----------------------------------50
4.2.8成品庫存管理與運銷作業銷貨退回-------------------------50
4.3可追溯性情境模擬-2005年蠻牛飲料被下毒事件及後續處理------------51
4.3.1情境------------------------------------------------51
4.3.2模擬分析--------------------------------------------52
4.3.4事件結論--------------------------------------------52
第 5章 結論-------------------------------------------------------53
第 6 章 參考文獻---------------------------------------------------54
中文部分
1.現行藥品優良製造規範(2002)-電腦化系統確效指導手冊,行政院衛生署
2.電腦化系統確效作業研習班(1)(2)(3)講義(2003),社團法人中華無菌製劑協會
3.國際醫藥品稽查協約組織(PIC/S)藥品優良製造規範指導手冊(2007),行政院衛生署
4.94年度經濟部聯合技術協助訓練進修實施計畫(2006)-藥廠GMP訓練,出國報告,夏蓉蓉
5.軟體能力模式CMM/CMMI 上課講義V2.1版(2004/09),張文貴
外文部分
6.A WHO Guide to Good Manufacturing Practice(GMP)requirements part
2:Validation,World Health Organization,1997
7.The Good Automated Manufacturing Practice (GAMP) Guide for
Validation of Automated Systems GAMP 4,ISPE,2003
8.Guide to Good Manufacturing Practice(GMP)for Medicinal Products
(Annex11),PIC/S,2007
9.GOOD PRACTICES FOR COMPUTERISED SYSTEM IN REGULATED "GXP"
ENVIRONMENTS,PIC/S,2004
10.General Principles of Software Validation;Final Guidance for
Industry and FDA Staff,January ,Center for Devices and
Radiological Health,2002
11.Guidance for Industry Quality System Approach to Pharmaceutical
CGMP Regulations,Pharmaceutical CGMPs,2006
12.Guidance for Industry Part 11, Electronic Record;Electronic
Signatures-Scope and Application,FDA,2003
13.GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL
INGREDIENTS,ICH Harmonised Tripartite Guideline,2000
14.CMMI Distilled A Practical Introduction to Integrated Process
Improvement,Dennis M.Ahern,Aaron Clouse,and Richard Turner,2001
15.CMMI SE/SW/IPPD/SS,V1.1 Staged CMMI 1.1,March 2002
http://www.sei.cmu.edu/cmmi/
16.CMMI® for Development, Version 1.2,CMMI Product Team,August 2006
http://www.sei.cmu.edu/cmmi/
17.Practical Guide to Software Quality Management,Second
Edition,John W. Horch,2003
18.Introduction to the Personal Software Process,Watts S.
Humphrey,1997
19.Introduction to the Team Software Process,Watts S. Humphrey,1999
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