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Qualified Persons: what they do and how you can become one

机译:合格人员:他们的工作以及如何成为一体

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摘要

Qualified Persons have a wide impact on patient care by assuring the quality of all medicines manufactured for the European market. A QP is legally responsible for certifying that each batch of a medicinal product is suitable for release for sale or for use in a clinical trial, and will be named on the manufacturer's authorisation. QPs are essential in the quality assurance of medicines and are responsible for ensuring that good manufacturing practice is in place. If there are any changes in manufacturing or quality control the QP will assess whether these impact on product quality.
机译:合格人员通过确保为欧洲市场生产的所有药品的质量,对患者的护理产生广泛的影响。 QP具有法律责任,负责证明每批次的药用产品都适合发布销售或用于临床试验,并将在制造商的授权上进行命名。 QP对药品的质量保证至关重要,并负责确保良好的生产规范。如果生产或质量控制发生任何变化,QP将评估这些变化是否对产品质量产生影响。

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