GMPs & Quality Assurance
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.
