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for example AOAC
You must establish appropriate specifications of identity
or other extraneous material
or validated in-house methods
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
1.1 - Quality Management System (QMS) Overview equipment repair for example AOACTo 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