1.1 - Quality Management System (QMS) Overview equipment repair must be documented as part

must be documented as part of the QMS

Any physical plant you use in the manufacture

or validated in-house methods

for example AOAC

There shall be separate or defined areas necessary to prevent contamination or mix-ups during receipt

1.1 - Quality Management System (QMS) Overview equipment repair must be documented as partTo 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