2.1 - Production & Quality Management Sub-Part N Quality risk management is a

Quality risk management is a systematic process for the assessment

Methods requiring validation must be added to the VMP

Any physical plant you use in the manufacture

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

and purity

2.1 - Production & Quality Management Sub-Part N Quality risk management is aThere 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