1.1 - Quality Management System (QMS) Overview equipment repair Any physical plant you use

Any physical plant you use in the manufacture

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

or validated in-house methods

must be documented as part of the QMS

1.1 - Quality Management System (QMS) Overview equipment repair Any physical plant you useTo 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