Technical Talk: Good Manufacturing Practice in FDA Regulated Facilities
Food packaging materials that are sold or marketed in the United States are subject to various regulatory and legal requirements – many of which are set forth by the U.S. Food and Drug Administration (FDA). In addition to meeting various compositional and purity requirements, FDA also requires that appropriate measures be taken to ensure that these materials are “safe and suitable” for their intended use. FDA’s Good Manufacturing Practice (GMP) requirement is both broad-reaching and essential, but largely silent on specific requirements. Therefore, material manufacturers, converters, and customers must determine how best to ensure that the GMP requirement is satisfied. Principles of Industrial Engineering play a critical role in accomplishing this objective.