GMPs & Quality Assurance

GMPs and Quality at Herb Pharm

Clockwise from top left:

Inspecting and receiving a shipment of Schisandra berries

QA makes sure that the St. John's Wort flowers are of optimal size for the highest medicinal value

QA reserves a sample of Stillingia root for batch to batch recording

Testing herbs with the Soleris Rapid Optical Microbiological Detection System

The "Plant Plant"
Our new 16,000 square-foot "Plant Plant" is an FDA-audited and Good Manufacturing Practices (GMP)-compliant manufacturing facility where we produce our herbal extracts. It is located just two miles from our Pharm Farm which assures prompt delivery of freshly-harvested herbs directly from the fields, or recently-dried herbs directly from the farm's drying loft. Here we also receive other organic and wildcrafted herbs from various parts of the USA and world.

Traditional Extraction Fundamentals Integrated With Modern Science & Technology
We know that the centuries-proven fundamentals of herbal extraction are indispensable and timeless. However, by incorporating 21st-Century science and technology, we are able to perfect the application of these fundamentals, and thereby produce superior quality extracts.

When producing our herbal liquid extracts and alcohol-free glycerites we use certified-organic, pharmaceutical-grade grain alcohol, distilled water, and/or pharmaceutical-grade glycerine (made from coconut and palm oil). To produce our herbal oil extracts we use certified organic, unrefined olive oil.

Each herb is custom extracted according to its own unique bio-chemical profile and physical characteristics, and in a manner that assures a broad-spectrum extract that is rich in the aroma, flavor and bio-activity of the original herb itself. Calling our extracts unrefined is actually a compliment.

Good Manufacturing Practices
Throughout the literally hundreds of steps of our manufacturing processes from planting the fields to shipping out the finished products each and every step is controlled through FDA-mandated Good Manufacturing Practices and by strict inspections by our Analytical Laboratory, and Quality Assurance and Sanitation Departments. Our standard operating procedures include ongoing staff training, herb identity verification, raw material inspection and inventory control, equipment maintenance, chemical testing, strict sanitation controls, storage and inventory control of finished goods, accounting of all product shipped and full documentation of each and every step.

"Seed to Shelf" Quality Control
In every phase of our process, our Quality Control Department and Analytical Laboratory are busy ensuring that our materials and finished goods meet our strict specifications. Microbiological testing (checking for bacteria and other organisms that shouldn't be there) is performed on incoming lots of herbal raw product when deemed necessary according to risk analysis and/or product history. We test all finished batches organoleptically (taste, odor, appearance) and microbiologically to insure compliance, consistency and safety, as well as insuring our compliance to any label claims.

In addition, we perform extensive microbiological and allergen testing on product contact areas, containers, packaging, and a variety of processing equipment.

Herb Pharm's microbiological testing is performed in real-time on a state-of-the-art optical system. This system delivers quality data of vital importance by use of rapid optical detection of microbial contamination. The system enables us to screen raw materials, finished batches, or environments for early detection of contamination and positive release of finished product. Instead of waiting days for accurate results from a third-party testing facility, we now have this information in a matter of hours.

Our "seed to shelf" approach to extract manufacturing is certainly a lot of work, but that's OK with us because it enables us to produce superior quality herbal extracts.

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