Manufacturing Overview
ProThera nutraceuticals 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 ProThera 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 by raw material vendors and ProThera, Inc. 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
ProThera products are free of artificial flavors, preservatives,
and colorings. Naturally-derived, inert excipient materials,
including
cellulose-based excipients, vegetable-derived magnesium stearate,
L-leucine, 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. Vegetarian
Vcaps™ capsules made of plant cellulose are used exclusively
for ProThera's two-piece encapsulated products. Common allergens
such as wheat, corn, soy, yeast, and dairy are avoided.
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