1.0 - Drug Definitions used in 21 CFR 211 internal audit in an unopened state

in an unopened state

must be used to confirm these parameters on a periodic basis

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

processing

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 in an unopened stateThe 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