辉瑞企业培训资料
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 availabilityGood pharmaceutical quality represents an acceptably low risk of failing t ...