Eudralex Chapter 1 - QMS

1.1 - QMS Overview

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To ensure pharmaceutical products are fit for their intended use, and do not place patients at risk due to inadequate safety, quality or efficacy, there must be a comprehensively designed and correctly implemented Pharmaceutical Quality System incorporating Good Manufacturing Practice and Quality Risk Management. The attainment of this quality objective is the responsibility of senior management.

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Pair of hands around a cog systems symbol and a group of three people to signify a quality management system