Over the decades following the enactment of the Food Drug and Cosmetic Act (FDCA) in 1938, controversy has existed over the need and extent of regulation of the manufacture and distribution of dietary supplements. Early on, dietary supplements were seen as an extension of foods and were later regulated within the food cGMP’s under 21 CFR Part 110, with distinctions defining them from food additives. At the same time, herbal and botanical preparations and ingredients were considered a special class of compounds which were thought to be safer than chemically derived food substances, and achieved a separate and more liberal treatment than other substances. Over time, greater sophistication in the marketplace and the widespread uptake of dietary supplements and natural products by consumers spurred tighter regulation, based on the government’s recognition and experience with the risks inherent in the introduction of new ingredients, formulas and categories of dietary supplements. This was actualized in the passage of the Dietary Supplement Health and Education Act (DSA) of 1994, which authorized the promulgation of cGMP’s for dietary supplements.
With the promulgation of the latest 21 CFR Part 111 regulations in 2007 (phased in over 3 years), dietary supplements have achieved a near peer status to pharmaceutical product compliance status; thus the moniker “Nutraceutical” is becoming a more worthy distinction for products that meet the new standard.
The regulation adopts nearly identical provisions of compliance as the pharmaceutical cGMP regulations in the areas of:
- Personnel management and training
- Physical plant, equipment design and management
- Product specification, master and batch records and labeling
- Production, packaging, material receipt, holding and finished goods distribution and returns
- QA/QC processes and laboratory requirements
- Deviations and corrective action
- Consumer complaints
- Procedure and record keeping documentation, and record retention for above items
To address the burdensome documentation requirements of the regulations, leading nutraceutical and dietary supplement manufacturers are adopting the same supporting computer systems for the supply chain, quality assurance and document management functions from the already established pharmaceutical domain, using risk based validation testing processes based on FDA and GAMP 5 guidance scaled to the requirements of Part 111.
USDM has experience over several years assisting leading nutraceutical manufacturers to navigate the electronic records transition quickly and cost effectively. Let USDM’s deep expertise and validation accelerators speed your journey to compliance, with a program tailored to your specific needs. USDM can help you rapidly assess your system and compliance needs and risks, develop comprehensive plans and execute projects which meet regulatory requirements at lowest cost while improving your business processes.
To learn more about USDM and how we can assist you with your compliance related initiatives, please contact:
Rebecca Meledy
888.231.0816 x 161
775.213.5943 (fax)
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