GMP Issues

If you are a manufacturer, packager, distributor, importer, or exporter of foods, drugs, 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 good manufacturing practice regulations for conventional foods, specific regulations have been developed for dietary supplements.  Because of the dosage form similarities between drugs and dietary supplements, the dietary supplement GMPs have much more in common with the drug GMPs than they do with the GMPs for conventional foods.


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.


   Print-friendly version of the FDA regulations


For more information about GMP practices, you can also visit: www.fda.gov

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