Essential
Therapeutics
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Quality
Statement concerning Essential Therapeutics
Supplements
Essential Therapeutics products are produced in licensed
manufacturing facilities that strictly adhere to current
Good Manufacturing Practices (cGMP's). Products provided in
tablet, capsule, and powder form are made in a
manufacturing facility licensed by the State of California
as a drug manufacturer and food processor and registered
with the Food and Drug Administration as a drug
manufacturing establishment. The facility is also approved
by governmental agencies in the United Kingdom, the
European Community (EC) and Australia to manufacture a drug
product. Current GMP's and written standard operating
procedures (SOP's) are strictly followed through all stages
of production to produce products that meet or exceed
United States Pharmacopeia (USP) standards.
Raw Material
Specifications
Active ingredients used in Essential Therapeutics products
are selected based on their purity, bioavailability,
documented actions, and safety characteristics. USP
materials, i.e., those meeting USP standards, are used for
those nutrients where this standard exists. Raw materials
are purchased exclusively from reputable vendors who
provide detailed Certificates of Analysis for every lot of
material. These certificates certify that active
components, toxic elements, and microbial content are
within specified acceptable parameters. Purity and potency
of selected raw materials are verified through independent
testing laboratories. All incoming raw materials undergo
quarantine, inspection, and evaluation.
Quality Control
Laboratory
On-site laboratory personnel evaluate physical
characteristics of each finished product including
hardness, disintegration, moisture balance, friability, and
pH. Purity and potency of finished product is independently
verified through outside commercial laboratories using a
randomized ingredient and batch testing program.
Excipients
Essential Therapeutics products are free of artificial
flavors, preservatives, and colorings. Naturally-derived,
inert excipient materials, including cellulose-based
excipients, vegetable-derived magnesium stearate, and
silicon dioxide are used in very small amounts as tableting
and encapsulation aids. Tableted products are protected
with an inert, water-soluble cellulose coating that
dissolves readily upon ingestion, thus facilitating tablet
disintegration time.
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