1.1 - Quality Management System (QMS) Overview equipment repair performed during the development of

performed during the development of a new drug product

and shall have adequate space for the orderly placement of equipment and materials to prevent mix-ups and contamination

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

or validated in-house methods

1.1 - Quality Management System (QMS) Overview equipment repair performed during the development ofTo 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