| 課程編碼 Course Code | 中文課程名稱 Course Name (Chinese) | 英文課程名稱 Course Name (English) | 總學分數 Credits | 總時數 Hours |
|---|---|---|---|---|
| 3204111 | 生技產品GMP概論與實習 | Introduction and Laboratory of GMP for biotech products | 2.0 | 2 |
| 中文概述 Chinese Description | 新興生技產品的生產製造過程，絕大部分都受到不同的GMP規範，而這些GMP規範又有別於機械，電子，化工產品的GMP規範，這也是台灣生技廠的業者迫切希望學校能教授的專業課目之一。由於生技產品GMP是跟著個別產品量身訂做的，因此本課程將選定一產品，然後依序從GMP法規的概述與要求，生技GMP品質系統，標準製造流程的建立，生產流程與GMP文件之建構，到最後的實習操作與實地GMP廠查核。 | |||
| 英文概述 English Description | Most of the newly emerged biotech products must follow their GMP guidance, which is different from the GMP in mechanical, electronic, and chemical engineering products. According to the GMP guidance is depend on the biotechnical products, this course will teach and train students the following topics: the general introduction and the requests of GMP guidance, the system of quality requirement, the establishment of standard operation protocol, the establishment of documents and how to fill in it, and the practical training and the factory auditing. | |||
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