關於藥品檢驗結果OOS的調查(doc 17頁)

關於藥品檢驗結果OOS的調查目錄：
I. INTRODUCTION 序言…… 1
II. BACKGROUND背景…………1
III. IDENTIFYING AND ASSESSING OOS TEST RESULTS OOS檢驗結果的判斷和評估 …… 2
A.Responsibility of the Analyst 檢驗員的責任………2
B. Responsibilities of the Supervisor主管的責任……3
IV. INVESTIGATING OOS TEST RESULTSOOS 檢驗結果的調查…5
A. General Investigational Principles 一般調查原則……5
B. Laboratory Phase of an Investigation實驗室的調查階段 ……6
V. CONCLUDING THE INVESTIGATION 調查結論 ……10
A. Interpretation of Investigation Results調查結果的解釋 ……10
B. Reporting報告 ………… 11

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