| 姓名 |
王品洋(wang pin-yang)
查詢紙本館藏 |
畢業系所 |
高階主管企管碩士班 |
| 論文名稱 |
製藥業原物料研發與生產流程管理之研究
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| 相關論文 | |
| 檔案 |
 [Endnote RIS 格式]
[Bibtex 格式]
 [相關文章]  [文章引用]  [完整記錄]  [館藏目錄]  至系統瀏覽論文 ( 永不開放)
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| 摘要(中) |
在化學材料配方代工行業，研發階段的記錄優化是提升産品質量、加快市場上市速度及確保法規遵循的關鍵因素。本文將探討傳統化學材料配方代工廠在研發過程中實施記錄優化的必要性，特別是在面對日益嚴格的國際標準和市場需求的背景下。
傳統上，化學材料配方代工廠的研發記錄多依賴於紙本文件，這一做法雖然直觀，但卻存在諸多不便。手工記錄易出錯，且難以迅速更新和共享。紙質記錄在存檔和檢索上的低效率，尤其在需要追溯或審核的情况下，往往造成顯著的時間延誤和資源浪費。這不僅影響研發進度，更可能導致符合規範性風險，威脅到企業的市場信譽和經營合法性。
隨著全球化的推進和技術的快速發展，化學材料配方代工行業的市場競爭愈發激烈。在這樣的市場環境下，能够快速將高質量的新産品推向市場的企業更具優勢。因此，研發記錄的效率和準確性直接影響了新産品開發的速度和質量。有效的記錄系統能够保證資料的完整性和準確性，加速産品從概念到市場的過程，同時減少由於記錄不當造成的成本浪費。
研發記錄的優化也是滿足法規要求和進行質量控制的基礎。在化學産品製造和配方開發中，需要符合越來越嚴格的環境、健康和安全標準。一套完善的記錄系統能够確保所有的研發活動和産品測試都有迹可循，從而滿足監管機構的審查需求。有效的記錄管理同時支持企業進行內部質量審核，及時發現問題並進行糾正，這對持續改進産品質量和研發流程至關重要。
基以上分析，本文將通過案例研究的方式，深入探討化學材料配方代工廠如何通過實施先進的産品生命週期管理（PLM）系統，來優化其研發記錄。這不僅有助提升研發效率和産品質量，也是企業應對市場和法規挑戰、保持競爭力的關鍵策略。 |
| 摘要(英) |
In the contract manufacturing industry of chemical material formulations, optimizing records during the R&D phase is crucial for enhancing product quality, accelerating market launch, and ensuring regulatory compliance. This paper discusses the necessity of implementing record optimization in traditional chemical material formulation contract manufacturing plants during the R&D process, especially in the context of increasingly strict international standards and market demands.Traditionally, R&D records in chemical material formulation contract manufacturing plants have relied heavily on paper documents. Although this method is intuitive, it poses several inconveniences. First, manual recording is prone to errors and is difficult to update and share quickly. Moreover, the inefficiency of paper records in archiving and retrieval, particularly in situations requiring traceability or audit, often results in significant time delays and resource wastage. This not only affects the progress of R&D but could also lead to compliance risks, threatening the market reputation and legal operation of the enterprise.
As globalization advances and technology rapidly evolves, the market competition in the chemical material formulation contract manufacturing industry becomes increasingly fierce. In such a market environment, companies that can quickly introduce high-quality new products to the market have a competitive advantage. Therefore, the efficiency and accuracy of R&D records directly impact the speed and quality of new product development. An effective record system ensures data integrity and accuracy, speeds up the product journey from concept to market, and reduces costs incurred by improper recording.
Moreover, the optimization of R&D records is also foundational for meeting regulatory requirements and conducting quality control. In the manufacturing and formulation development of chemical products, adherence to increasingly strict environmental, health, and safety standards is necessary. A comprehensive record system ensures that all R&D activities and product testing are traceable, thereby meeting the scrutiny of regulatory authorities. Effective record management also supports internal quality audits, facilitating timely problem detection and correction, which is crucial for continuous improvement in product quality and R&D processes.
Based on the above analysis, this paper will explore, through case studies, how chemical material formulation contract manufacturing plants can optimize their R&D records by implementing advanced Product Lifecycle Management (PLM) systems. This not only enhances R&D efficiency and product quality but is also a key strategy for enterprises to cope with market and regulatory challenges and maintain competitiveness. |
| 關鍵字(中) |
★ 化學材料配方代工行業
★ 研發
★ 産品生命週期管理 |
關鍵字(英) |
★ manufacturing industry of chemical material formulations
★ R&D
★ Product Lifecycle Management (PLM) |
| 論文目次 |
中文摘要 i
Abstract ii
誌謝 iv
目錄 v
圖目錄 vii
第一章 研究動機及目的 1
1.1 研究動機 1
1.2 研究目的 1
1.3 研究流程與架構 2
第二章 文獻探討及相關研究 4
第三章 個案介紹與問題分析 6
3.1 發展歷程與特性 6
3.2 應用領域及產品類別 7
第四章 公司簡介 8
4.1 個案公司 8
4.1.1. 研發流程及規範 10
4.1.2 新原料的實驗流程 12
4.1.3. 研發作業流程 13
4.1.4 資料控管機制 16
4.2 問題分析 17
4.3 面臨的挑戰 18
4.4 解決方案 19
4.5 流程可行性評估 22
第五章 結論與建議 24
5.1 結論 24
5.2 研究限制 25
參考文獻 26 |
| 參考文獻 |
1.Lee, J., & Kim, Y. (2020). PLM system optimization for pharmaceutical R&D process management. Journal of Pharmaceutical Management and Technology, 11(2), 88-95.
2.ones, S. P., & Roberts, L. A. (2020). Automation in pharmaceutical manufacturing: The role of data integrity. Journal of Pharmaceutical Quality Assurance, 35(2), 115-122.
3.Peterson, A. (2021). Role of PLM in enhancing data integrity and product quality in the pharmaceutical industry. PharmaTech Journal, 12(1), 24-30.
4.Smith, A. (2019). Enhancing drug development and manufacturing through data analytics. Journal of Pharmaceutical Innovation, 14(3), 204-211.
5.Thompson, H. (2022). Integrating PLM systems in pharmaceutical operations: Challenges and solutions. International Journal of Pharma Innovation, 13(4), 134-142.
6.Wilson, P. (2018). Regulatory compliance and drug manufacturing in the age of precision medicine. Regulatory Affairs Journal, 29(1), 34-42. |
| 指導教授 |
陳炫碩
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審核日期 |
2024-5-29 |
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