2.1 - Production & Quality Management Sub-Part N Any physical plant you use

Any physical plant you use in the manufacture

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

of materials or drug product must be examined visually for appropriate labeling as to contents

identified through a sound statistical sampling plan (or otherwise every finished batch)

Methods requiring validation must be added to the VMP

2.1 - Production & Quality Management Sub-Part N Any physical plant you useThere 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