品質控制單位──CGMP科學把關者   全文下載

Quality Control Unit-The Science Gatekeeper of CGMP Products

本文討論一個品質控制單位在把關藥品成品以滿足當今優良藥品製造規範的重要性，科學的結論及數據是回答大部分美國食品藥物管理局（Food and Drug Administration, FDA）的問題所需要的。實驗室的工作功能，即品管分析，分析方法及藥品穩定性指認方法與測試都包括在內。品管室的重要性也略述並簡短討論現今美國品管的最新趨勢，即將來製造廠可能可用“第一團體（First party）”或“第三團體（Third party）”來替FDA做實地檢查。分析方法驗證（Validation），正確的實驗數據記錄與解釋，藥品穩定性的確認與分析方法的指認程度與可靠性，規格（Specification）及儀器的校正與記錄皆是重要且耗時的工作。它們可能影響FDA對藥品成品的核准及決定一個實驗室與品管室是否能確保產品的優良品質。“再測試”與“訓練 ／ 合格測試”的問題也是達成品質管制的重點。"

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 comapny 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.