2.1 - Production & Quality Management Sub-Part N and purity

and purity

Thereafter they must be stored under quarantine until they have been tested or examined

You must verify that the laboratory examination and testing methodologies are appropriate for their intended use

as necessary

2.1 - Production & Quality Management Sub-Part N and purityThere shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated