中文摘要本研究使用實驗法，並建立複迴歸模型探討動物藥廠IQC、IPQC、FQC資料，進行現場訪談為原料藥的生產了解浪費問題。降低成本中，防止失敗成本幾乎是現在企業利潤的代名詞，因此積極有效的從製造過程中去防止異常的發生，將是提升企業利潤的另一有效手法。所以在降低成本中落實防止失敗成本的發生，是製造生產過程中不得不特別加以管控的一個環節。我們開展實驗後發現了多西環素原料藥儲存問題，因此產生的力價降解十分明顯，在八個月內降解了超過10%。本研究嘗試提出解決方案以解決藥廠原料成本浪費之議題：
1. 操作人員必須要有正確的操作標準書 (S.O.P)。
2. 大量生產開始，對第一件製品是要?實做好首件檢查 (S.A.I)的工作。
3. 嚴格要求依照檢查標準書 (S.I.P) 之規定，執行製程中產品之檢查。
4. 生產記錄必須與規定之檢查頻率相符，確實記紀錄品品質記錄，並存檔備查。
5. 落實應用 SPC (統計製程管制) 手法來解析製程問題及管制製程的變異，保證品質是有效的被控管。
6. 品保部門應針對爭議事實明確表達，迅速讓製造部澄清疑點，減少不必要的爭議。
若能執行正確落實降低浪費成本之方案，我們期許能夠後續再進行原料採購策略之研究。 Abstract This study used the experimental method and established a complex regression model to explore the IQC, IPQC, and FQC data of animal drug factories, and conducted on-site interviews to understand the waste problem in the production of APIs.In reducing costs, preventing costs of failure is almost synonymous with corporate profits. Therefore, actively and effectively preventing the occurrence of business failures in the manufacturing process will be another effective way to increase corporate profits. Therefore, the implementation of prevention of failure costs in reducing costs is a part of the manufacturing process that has to be specifically controlled. We conduct information on IQC, IPQC, and FQC for an animal pharmaceutical factory and carry out on-site interviews to find waste for the production of raw materials.We had found that the storage problems of the raw materials of doxycycline, the resulting degradation of the potency was very obvious, degrading more than 10% within eight months. This study tried to propose a solution to save the solution to the waste of raw material costs at the manufacture,such as:
1. The operator must have a correct operating standard (S.O.P.).
2. Mass production begins. For the first product, the first inspection (S.A.I) must be carried out.
3. Strictly require the inspection of products in the manufacturing process in accordance with the provisions of the Inspection Standards (S.I.P.).
4. The production record must be consistent with the specified inspection frequency. The product quality record is actually recorded and filed for future reference.
5. Implement the SPC (Statistical Process Control) method to analyze the process problems and changes in the control process to ensure that quality is effectively controlled.
6. The quality assurance department should clearly express the facts of the dispute and promptly let the manufacturing department clarify the doubt and reduce unnecessary disputes.
If the factory can correctly implementing the plan to reduce waste costs, we expect to be able to follow up on the study of raw material procurement strategies.
