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

or contact surfaces

You must identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required to determine whether the specification is met

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