2.1 - Production & Quality Management Sub-Part N You must establish appropriate specifications

You must establish appropriate specifications of identity

and purity

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

as necessary

Quality risk management is a systematic process for the assessment

2.1 - Production & Quality Management Sub-Part N You must establish appropriate specificationsThere 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