R. FLORA & ASSOCIATES, INC.

GMP Issues

If you are a manufacturer, packager, distributor, importer, or exporter of foods, drugs, cosmetics, or dietary supplements, there are good manufacturing practice (GMP) issues that you need to be aware of and may need to comply with.

R. FLORA & ASSOCIATES, INC. can help you make sense of all the regulations and paperwork.

Besides the general requirements, specific regulations have been developed for thermally processed low-acid foods packaged in hermetically sealed containers, acidified foods, shell eggs, fruit and vegetable juices, fish and fishery products, bottled drinking water, infant formula, and animal food. There are also GMP requirements for irradiated food and for substances that are approved food additives, approved color additives, generally recognized as safe (GRAS) or subject to prior sanctions which are incorporated into the irradiation, food additive, color additive, GRAS, and prior sanction regulations. GMP requirements governing the production of organically produced foods are administered by the Department of Agriculture.

Establishments engaged solely in harvesting, storing, or distributing raw agricultural commodities that are cleaned, treated, or processed before marketing are not subject to the GMP regulations. However, the FDA is prepared to issue special regulations to cover these operations if necessary.

Under the FDA Food Safety Modernization Act, enacted on January 11, 2011, hazard analysis critical control point (HACCP) plans are now applicable to all food facilities, with the exception of very small businesses and small businesses as will be defined in future rulemaking by the FDA. Qualified facilities, defined as entities with sales under $500,000 per annual average, will also be subject to modified HACCP plans.

R. FLORA & ASSOCIATES, INC. can help you to understand and comply with these complex and, sometimes, difficult to understand regulations by answering your questions, making blind inquiries to FDA or other regulatory agencies on your behalf, auditing your facilities and/or documentation, helping with the development of your procedures, controls, and documentation, and helping with the preparation of your SOPs.