Good Manufacturing Practice (GMP) in the Pharmaceutical and Food Industries

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Researched by Industrialinfo.com (Industrial Information Resources, Incorporated; Houston, Texas). When selling equipment to the more than 10,000 plants that make up the pharmaceutical and food products industries in the U.S., it is necessary that the equipment meet the GMP performance standards set by the Food and Drug Administration (FDA). Such standards are set by the FDA for eight categories of products: food, drugs (including active ingredients and finished products), medical devices, biologics, animal feed and veterinary medicines, cosmetics, radiation devices, and combination products. For instance, equipment performance standards for making drug active ingredients are provided on the Internet at FDA GMP Guidelines. Major areas of concern for operating an active pharmaceutical ingredient (API) plant so as to practice GMP standards include the following categories: Quality Management, Storing, Building and Personnel, Laboratory Control, Facilities, Validation, Process Equipment, Complaints, Record Keeping, Contract Manufacturing, Materials Management, Agents, Process Controls, Cell Culture, Packaging, and Clinical Trials.

There are, in addition, GMP guidelines for all of the categories of foods and drugs previously listed. These guidelines can be reached on the Internet at the FDA's Home Page and then following instructions to reach the desired links.

According to Industrialinfo.com's North American Industrial Database, there are more than 10,000 major Food & Beverage industry, and Pharmaceutical & Biotech industry plants, which are affected by the FDA's GMP guidelines. The majority of these plants, 8,760 are Food & Beverage related. The remaining 1,342 plants are in the Pharmaceutical & Biotech industry.

Click on the image at right to view a regional breakdown of these plants.

It is advisable that equipment vendors who wish to sell to food and pharmaceutical plants be on the approved bidders list, that they receive approval directly from the ultimate user and that the equipment 1) meets buyer's vendor endorsement, and 2) that the equipment meets FDA's GMP standards for the intended service. Usually, there is one person at the plant who can endorse approvals for both 1) and 2) above. The FDA does not directly endorse any single brand of product that meets FDA GMP standards.

Pharmaceutical and food plants are inspected by the FDA to make sure the plants meet GMP compliance, and can be warned, fined, or even shut down completely, if GMP standards are not met. Much of the plant compliance approval rests on good original equipment and design of the plant itself, as well as on operating procedures at the plant.

For more information of the more than 10,000 plants mentioned in this article, such as plant and project contact names, addresses, phone number and more, contact Industrialinfo.com's Member Center at 1-800-762-3361.

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