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There shall be separate or defined areas necessary to prevent contamination or mix-ups during receipt
performed during the development of a new drug product
Any physical plant you use in the manufacture
such as head
1.1 - Quality Management System (QMS) Overview equipment repair There shall be separate orTo 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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