2.1 - Production & Quality Management Sub-Part N Methods requiring validation must be

Methods requiring validation must be added to the VMP

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

as necessary

and sanitizing operations

Quality risk management is a systematic process for the assessment

2.1 - Production & Quality Management Sub-Part N Methods requiring validation must beThere 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