FDA Compliance 2011 - Compliance with FDA’s Current Manufacturing Requirements

Why Should You Attend:
Recently FDA announced an aggressive campaign to enforce the Good Manufacturing Practices (GMP) regulation on manufacturers and suppliers of dietary supplements in the US. Also, a vast majority of supplements are imported from manufacturers located in countries with poor GMP requirements for such products.

To address these issues, FDA now requires manufacturers of dietary supplements to follow GMP requirements closer to those for drugs than those for foods. These requirements include stricter documentation, standardized processes, use of trained personnel, adequately designed facilities, quality testing, packaging and shipping, and audit trails of processes. These requirements have created lots of anxiety in an industry filled with small businesses with few products, and international companies marketing in the US.

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Compliance techniques can be simple and implemented with relative ease leading to better products both in terms of quality and potential benefit to consumers leading to better acceptance.