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

and glassware

You must establish appropriate specifications of identity

as necessary

and sanitizing operations

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

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