1.0 - Drug Definitions used in 21 CFR 211 internal audit You must take representative samples

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

must be used to confirm these parameters on a periodic basis

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

and contact surfaces you must take measures to exclude from any operations any person who in the opinion of a supervisor appears to have a health condition such as illness

1.0 - Drug Definitions used in 21 CFR 211 internal audit You must take representative samplesThe 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