Zdrowie i gospodarka · 09/07/1996
Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for the Production of Infant Formula
The Food and Drug Administration (FDA) is proposing to revise its infant formula regulations to establish requirements for quality factors and current good manufacturing practice (CGMP); to amend its quality control procedure, notification, and records and report requirements for infant formulas; to require that infant formulas contain, and be tested for, required nutrients and for any nutrient added by the manufacturer throughout their shelf life, and that they be produced under strict microbiological controls; and to require that manufacturers implement the CGMP and quality control procedure requirements by establishing a production and in-process control system of their own design. This action is being taken to improve the protection of infants that use infant formula products.