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must be documented as part of the QMS
and shall have adequate space for the orderly placement of equipment and materials to prevent mix-ups and contamination
or distribution record associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or
such as head
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
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