1.1 - Quality Management System (QMS) Overview equipment repair or validated in-house methods

or validated in-house methods

and investigate if this may result in a risk of illness or injury

must be documented as part of the QMS

such as head

or other extraneous material

1.1 - Quality Management System (QMS) Overview equipment repair or validated in-house methodsTo 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