輝瑞企業培訓資料（英）(ppt 36頁)

輝瑞企業培訓資料（英）內容簡介：
What is pharmaceutical quality?
consistent delivery of the label performance and lack of contamination.
operationalzed via a set of pre-specified quality attributes (e.g., specifications, limits) and through the CGMP regulations.
FDA, in its quality definition, is standing in for the customer—and it is apparent that health care practitioners and patients highly value an additional drug attribute: product availability
Good pharmaceutical quality represents an acceptably low risk of failing to achieve the desired clinical attributes.

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