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Quality Process

How are ingredients chosen?
Our formulator utilizes the most modern research in science and nutrition to pick the optimal ingredients for supporting a variety of health needs.  Once it is determined what ingredients  are going to go into product, our formulator discusses with the  production manager who sources them from a variety of suppliers.

How do you choose your suppliers?
Suppliers are based on reputation, availability, and quality.  Quality is based on existing documentation of raw material. We look at their Certificate of Analysis (COA) on raw materials which test for microbiology and heavy metals. If further testing is needed we will send their materials out for independent analysis. This is often done for multiple suppliers of unique ingredients and we would then choose the ingredient that fares the best in testing.

What other means of quality control are used?
Once a supplier is chosen a raw material is sent to the manufacturer where it is then tested for identity and a COA is also done. A COA tests for microbiology (yeast, e. coli salmonella and staff bacteria, mold, and fungus) and heavy metals (arsenic, lead, mercury, aluminum, etc.). Levels have to be below a certain threshold as determined by Association of Official Analytical Chemists (AOAC) and American Public Health Association (APHA) which set global standards for quality of ingredients. A manufacturer will reject a raw material if levels of any of the above are too high.

After a material is identified and the levels are accepted, it goes into storage at manufacturer site until production begins. At the time of production, materials are screened to make sure there is no foreign material present. They then go into a pre-blending room where they are weighed out per our formula, put in large v-blenders, re-packed into barrels and brought to filling room where the bottles are filled. The last step of the production process is to send out each final product to be tested for a COA and review reports for reports for any anomalies.

When a new run of product arrives in our warehouse we open one package of each SKU and make sure it has the proper number of servings, it mixes properly, and that it otherwise labeled properly.

What does GMP mean?
GMP stands for Good Manufacturing Practice. It is a production and testing practice put in place to ensure quality products. In the U.S. GMP standards are enforced by the Food and Drug Administration (FDA).
Here is an example of these practices as they pertain to raw materials and production:

1.    Raw Materials. Check whether:
a.    Raw materials and primary packaging materials are stored and handled in a manner which prevents their mix-up, contamination with microorganisms or other chemicals, or decomposition from exposure to excessive heat, cold, sunlight or moisture.
b.    Containers of materials are closed, and bagged or boxed materials are stored off the floor.
c.    Containers of materials are labeled with respect to identity, lot identification and control status.
d.    Materials are sampled and tested or examined in conformance with procedures assuring the absence of contamination with filth, microorganisms or other extraneous substances to the extent necessary to prevent adulteration of finished products. Pay particular attention to materials of animal or vegetable origin and those used in the manufacture of cosmetics by cold processing methods with respect to contamination with filth or microorganisms.
e.    Materials not meeting acceptance specifications are properly identified and controlled to prevent their use in cosmetics.

Production. Check whether manufacturing and control have been established and written instructions, i.e., formulations, processing, transfer and filling instructions, in-process control methods etc., are being maintained. Determine whether such procedures require that:
f.    The equipment for processing, transfer and filling the utensils, and the containers for holding raw and bulk materials are clean, in good repair and in sanitary condition.
g.    Only approved materials are used.
h.    Samples are taken, as appropriate, during and/or after processing, transfer or filling for testing for adequacy of mixing or other forms of processing, absence of hazardous microorganisms or chemical contaminants, and compliance with any other acceptance specification.
i.    Weighing and measuring of raw materials is checked by a second person, and containers holding the materials are properly identified.
j.    Major equipment, transfer lines, containers and tanks are used for processing, filling or holding cosmetics are identified to indicate contents, batch designation, control status and other pertinent information.
k.    Labels are examined for identity before labeling operations to avoid mix-up.
l.    The equipment for processing, holding, transferring and filling of batch is labeled regarding identity, batch identification and control status.
m.    Packages of finished products bear permanent code marks.

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