Part 111 of Title 21 of the Federal Code of Regulations provides for a complete set of provisions regarding the good manufacturing practices for packaging, labelling and storage/holding of products defined as human food dietary supplements. This Regulation also defines issues regarding the personnel; physical plant and grounds; equipment and utensils; requirement to establish a production and process control system; production and process control system: requirements for quality control, requirements for components, packaging, and labels and for product that you receive for packaging or labelling as a dietary supplement; production and process control system: requirements for the master manufacturing record, requirements for the batch production record; production and process control system: requirements for laboratory operations and requirements for manufacturing operations; production and process control system: requirements for packaging and labelling operations; retail and distribution; returned dietary supplements; product complaints; records and recordkeeping.
United States of America · 1986-06-19