1.0 - Drug Definitions used in 21 CFR 211 internal audit must be used to confirm

must be used to confirm these parameters on a periodic basis

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

monitoring

You must take representative samples of materials and dietary supplements of each unique lot within each unique shipment or manufactured batch to determine if specifications have been met

1.0 - Drug Definitions used in 21 CFR 211 internal audit must be used to confirmThe 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