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1.0 - Drug Definitions used in 21 CFR 211 internal audit monitoring

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Description

monitoring

quality or efficacy

or contact surfaces

The measures to prevent cross-contamination should be commensurate with the risks using Quality Risk Management principles to assess and control the risks

must be used to confirm these parameters on a periodic basis

1.0 - Drug Definitions used in 21 CFR 211 internal audit monitoringThe definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) apply to such terms when used in this part 21 CFR 211 for pharmaceuticals. For the purpose of this part, the following definitions also apply

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