Current good manufacturing practice in manufacturing, packaging, labelling, or holding operations for dietary supplements (21 CFR 111.1-111.610).
Country
Type of law
Regulation
Date of original text
Date of latest amendment
Abstract
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.
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.
Attached files
Web site
Notes
Official reprint dated 1 April 2015.
Repealed
No
Serial Imprint
Code of Federal Regulations - Title 21 - Food and Drugs.
Source language
English
Legislation Amendment
No