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GMP in Botanical Extractions

Monday, November 21, 2016

For many years, the herbal extractions industry was basically a “black market” venture, highly unregulated and potentially dangerous for the consumer. Today, however, botanical extractions have come into the mainstream, and today’s consumer is much more open to harnessing the many benefits of such extractions. As such, the FDA has stepped in, demanding that herbal extractions be regulated along with the foods, beverages, and body products our nation relies on.

GMP in the realm of botanical extractions ensures that all manufacturing processes are clearly documented and defined. Critical steps in the manufacturing process of a botanical extraction are documented, ensuring compliance with GMP. All operators are systematically trained to ensure seamless functioning, and comprehensive records document the manufacturing process, from start to finish.

GMP regulations also address the extraction setting. Is the space staffed with accurately qualified personnel at all times? Is there adequate space for the machinery and equipment? Is the manufacturer using modern, efficient, and effective equipment, or is that mixing equipment dated? Is attention being paid to selecting and using the correct materials, containers, and labels? Does the company provide suitable storage and transport of the end product? All extractions manufacturers must take these questions into account in order to assure compliance with GMP standards.

Comprehensive audits ensure GMP regulation across industries – and the extractions sector is no exception. Auditors will assess the caliber of personnel; the maintenance of grounds, buildings, and equipment; any quality control procedures in place; sanitation policies; and much more. With such strict regulations in place, there’s little space for error, and today’s extraction market boasts a higher quality selection than ever before. The botanical extract consumer never had it so good.

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