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Good Supplement Manufacturing Practices: GMP Specifications

Supplement manufacturing facilities following Good Manufacturing Practices are expected to set, meet and document specifications for all incoming and outgoing materials. Failure to do so could lead to a regulatory action such as an injunction. GMP Specifications are needed for:…

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Inventory Control Series Part 1: Suppliers and Specifications

Managing inventory in a way that is compliant with GMP can be challenging. Regulatory measures specific to handling inventory are included in the Dietary Supplement Health and Education Act (DSHEA). The regulations apply to all incoming materials, work-in-progress materials, and…

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Supply Side West: Industry Insights, Quality and GMP

Our Supply Side West experience began with unique insights about the natural products industry. Trending topics at the United Natural Products Alliance and Dan Fabricant's Keynote session included regulatory issues, contaminants, increased focus on claims and defining he word "natural".…

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Requirements for Raw Materials Testing

Another great question for a member of our GMP for Dietary Supplements group: Are there any specified requirements for raw materials testing? There are specific requirements to release raw materials which are based on the final product in which the…

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Air Pressure in a Supplement Manufacturing Facility

A member of our GMP for Dietary Supplements group recently inquired about positive air pressure requirements for dietary supplement manufacturing facilities. The short answer is no, there are no specific requirements and there's no minimum for differentiating pressure (DP) for…

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