頁籤選單縮合
| 題 名 | 中藥廠實施PIC/S GMP可行性評估=Evaluation of the Feasibility for Chinese Herbal Medicine Manufacturers to Adopt PIC/S GMP |
|---|---|
| 作 者 | 李世裕; | 書刊名 | 中醫藥年報 |
| 卷 期 | 3 2014.12[民103.12] |
| 頁 次 | 頁(90)1-(90)19 |
| 分類號 | 418.61 |
| 關鍵詞 | 中藥; 藥品優良製造規範; PIC/S; GMP; Chinese herb medicine; |
| 語 文 | 中文(Chinese) |
| 中文摘要 | GMP作業是確保藥品安全、品質、有效性之製造管理系統。目前 PIC/S的 GMP已被許多國家採用為標準,而中藥廠雖已在 2005年 9月 30日全面實施 GMP,然而與 PIC/S GMP仍有差距。為了中藥 GMP能與國際接軌,本計畫收集各中藥廠 GMP管理之現況資訊,進行國內中藥廠實施 PIC/S GMP可行性評估之研究,並透過專家小組討論會,研擬適合中藥廠實施 PIC/S GMP步驟與時程之建議案,以及適用之軟硬體規範與配套措施等等。規劃結果顯示出以採用主動自願實施 PIC/S GMP的方式,等到適當比例的中藥廠達到要求後,再進入到準備全面實施 PIC/S GMP的緩衝階段,比較能被中藥廠接受。唯未來中藥廠必須盡快的完成確效作業,才能順利銜接到 PIC/S GMP的階段。 |
| 英文摘要 | Good Manufacturing Practice (GMP) is an important management system to assure safety, quality, and efficacy of drugs. At the present time, PIC/S GMP is widely adopted as the standard for pharmaceutical GMP. Although the GMP regulation has been adopted by domestic manufacturers of Traditional Chinese Medicine since 2006, it has been shown that there are some differences. To engage with PIC/S GMP, the present projected was designed to study the feasibility of adopting PIC/S GMP for domestic Traditional Chinese Medicine manufacturers. To achieve the purpose, a questionnaire was sent to manufacturers, and the result of analysis was sent to a discussion committee to design an appropriate plan. The finalized plan was consisted of a two-stage schedule of adopting PIC/S GMP along with some additional suggestions. The result has found that an initial voluntary stage was favored, and a threshold of certain percentage of completion of inspection before proceeding to the second stage was proposed. However, most domestic manufacturers of Traditional Chinese Medicine have to complete product validation is required in the near future. |
本系統中英文摘要資訊取自各篇刊載內容。