FDA Compliance Manual For Dietary Supplements

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Updated May 7, 2021

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FOOD AND DRUG ADMINISTRATION - COMPLIANCE PROGRAM GUIDANCE MANUAL - CHAPTER 21 – FOOD COMPOSITION, STANDARDS, LABELING, AND ECONOMICS - DIETARY SUPPLEMENTS – FOREIGN AND DOMESTIC INSPECTIONS, SAMPLING, AND IMPORTS (IMPLEMENTATION DATE: 09/30/2020) - PDF | FDA.gov 

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The FDA recently made the following available online, Dietary Supplements, Import and Domestic - Ch 21 Food Composition, Standards, Labeling, and Economics - Food and Drug Administration (FDA) - Compliance Program Guidance Manual.

It's a great reference that should be reviewed by everybody in the dietary supplement sector. Of note:

1. Part III - Inspectional - a wonderful listing of things to pay attention to, in almost checklist fashion
2. Part V-A - GMP Violations - watch out! Don't commit any of these major deviations:

• Lack of master manufacturing records or significant requirements not included
• Lack of finished product release criteria or failure to test (all or subset of finished batches) or meet finished product release criteria critical to product safety and quality
• For significant dietary ingredients, e.g. those that make up the bulk of the product, failure to establish specifications for incoming material or failure to conduct identity testing
• No quality control review procedures or significant quality control procedures not implemented
• No batch records
• Significant physical plant deficiencies.

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