頁籤選單縮合
題 名 | 品質控制單位--CGMP的科學把關者=Quality Control Unit--The Science Gatekeeper of CGMP Products |
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作 者 | 蘇向陽; | 書刊名 | 藥物食品分析 |
卷 期 | 4:3 1996.09[民85.09] |
頁 次 | 頁197-201 |
分類號 | 418.41 |
關鍵詞 | 品管單位; 製藥實驗室; 現行優良製造規範; 實驗室控制; 製藥文件處理; Quality assurance unit; Pharmaceutical laboratory; Current good manufacturing practice; CGMP; Laboratory control; Pharmaceutical documentation; |
語 文 | 中文(Chinese) |
英文摘要 | The importance of the quality control unit to gatekeep pharmaceutical products to satisfy CGMP regulation is discussed. Scientific results and data are needed in most cases to answer FDA's questions. Laboratory's work functions, i.e. quality control (QC), analytical method development and validation (AM) and stability (STB) have been included. The role of quality assurance (QA) has been discussed briefly. Analytical method validation, stability indicating method development and validation, specification and standard testing method preparations are critical tasks that may affect FDA's approval of the product and decision on whether a quality control unit of a company can ensure the products' good quality. Also mentioned are the "retest","training/qualification" and "calibration of instruments" issues. A discussion is also made on the most recent trend in the US for considering using the first party or the third party to audit or inspect facilities to lessen the FDA's burden on frequent inspection. |
本系統中英文摘要資訊取自各篇刊載內容。