Getting to Good: Good Manufacturing Practice in FDA Regulated Facilities

February 1, 2018

By Keller and Heckman LLP’s Packaging Practice Group

Companies that are directly or indirectly regulated by the U.S. Food and Drug Administration (FDA) – including those that manufacture food, food packaging, medical devices and drugs – are responsible for ensuring that their products are produced safely and consistently. The degree to which a company must meet these obligations depends on the intended or reasonably foreseeable use of the product. Ultimately, industry must ensure that its products are used in a manner that promotes consumer confidence, brand loyalty and, above all, protection of the public health.

Although industry has demonstrated a high degree of competency in this regard, notable exceptions have occasionally tested consumer confidence and placed additional challenges on manufacturers, converters, logistics providers and retail facilities to ensure that their products are manufactured, processed and handled with the highest degree of proficiency and diligence. Considering these responsibilities, FDA has wisely prescribed varying degrees of regulatory oversight depending on the risk profile of the product.

In the context of food-contact materials, however, the agency has implemented only a broad standard for ensuring that products are safe and suitable for their intended use. It is largely a company’s responsibility, therefore, to ensure that a high degree of safety and quality is continuously met. To meet these obligations, companies often rely on fundamental principles of industrial engineering, including facility design, process control, operations management and auditing.

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This article is provided with permission of the Institute of Industrial and Systems Engineers from the January 2018 issue of ISE, Copyright ©2018 Institute of Industrial and Systems Engineers. All rights reserved.