SolaRx
Health Solutions
SolaRx
Health Solutions goal
is to provide the finest quality supplements available
anywhere.
We are proud to offer GlucosRx™, made
only from the finest pharmaceutical grade ingredients
available
with clinical
testing of its affectiveness
and efficacy.
Contact Information
Mailing Address:
SolaRx Health Solutions
850 N.W. Federal Highway, Ste 189
Stuart, FL 34996
866-513-2612
772-382-1411
info solarxhealth.com
Quality Control
All of our raw materials
must pass stringent quality controls before they
are utilized.
In addition, only those precursor materials
that are of the highest quality and pass a quality
inspection are used.
All raw materials are tested for purity
prior to production. Quality control engineers have
the authority during any stage of production to reject
any product that does not adhere to our strict quality
standards. All personnel follow explicit written
protocols that are strictly enforced during the manufacturing
process. All steps during the manufacturing process
are documented and reviewed by quality control specialists.
Manufacturing equipment is properly maintained and
cleaned on a predetermined schedule that is documented
in company logs for review by the Department of Agriculture.
This helps to ensure the absence of any contamination
during the manufacturing process. Production records
associated with each unit of a product, including
all raw materials used, are filed for two years past
the expiration date.
Further quality control is
demonstrated by:
Product
analysis -
This is recorded for each product that is manufactured.
The analysis contains the specific components of
the herbal product, including a lot number for each
of the ingredients, as well as the production methods
used.
Raw materials - These
are purchased only from reputable wholesalers. Each
raw material in our products must come with a Certificate
of Analysis obtained from the supplier. Our in house
Quality Assurance team also analyzes the raw materials
for authenticity.
Packaging material -
All packaging materials are purchased only from reputable
wholesalers. Specific Quality Assurance personal
ensure that all labels are assigned to the proper
products to avoid any confusion. All new labels are
cross checked with the original master label to make certain
that there have been no mistakes during the printing
process.
Lot Numbers - Once
an order request has been received, the herbal supplement
to be manufactured is entered in the production records
and a lot number is assigned. The raw materials are
released to the pharmacy after all products have
been checked for authenticity.
Manufacturing
Guidelines
In addition to the protocols
described above, the makers of GlucosRx™ adheres
to the following manufacturing guidelines to ensure
the
utmost quality
control:
Blending and Granulation -
All equipment used in the process of mixing and granulation
is inspected by the Director of Operations prior
to use. Raw materials are then inspected for the
final time. The lots are then processed using strict
written guidelines for each herbal product. Following
granulation and blending, the powder blends are stored
in specially designed containers to ensure freshness
and to avoid any contamination. Once again the Director
of Operations ensures that all new blends are labeled
appropriately.
Tabletization and Compression -
Once a test unit has been processed, a sample unit
is issued to Quality Assurance to be compared to
retained samples in order to ensure product integrity.
Once the new unit has been approved by Quality Assurance,
full line production may begin. Quality Assurance
inspections are conducted using set protocols for
the caplets. As with the blending and granulation
process, the caplets are stored in specifically designed
containers to ensure freshness and to avoid any contamination.
The Director of Operations makes certain that all
new capsules are labeled appropriately.
Packaging and Inspection -
Upon completion of processing, the final product
is inspected again by the Quality Assurance staff.
Broken caplets, and any other defective products
are removed from the lot. Products released by the
Quality Assurance staff are subsequently either packaged
for bulk storage or bottled and labeled for consumer
use (labels contain the appropriate information required
by the Federal Drug Administration; batch numbers
are logged). All finished products are properly labeled
and closed with a tamper proof seal. The Quality
Assurance unit also retains samples of raw materials
for one year past the expiration date of the last
product they are used in. The unit also retains samples
of finished products for one year past the product
expiration date. These samples are maintained under
controlled conditions.
Final Products - All
final products are stored in quarantine in a climate
controlled environment until final delivery to the
customer.
All supplements
are manufactured using Good Manufacturing Practices
set forth by the US Food and Drug Administration.
In addition, both scheduled and surprise inspections
by the Quality Assurance staff during different aspects
of the manufacturing process help to ensure specific
quality, strength and purity for both the raw materials
and the finished supplements.
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. . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . GlucosRx™ Phase
1, Randomized, Double-Blind,
Placebo Controlled, Human Clinical Study
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