Our "Difference" in Good Manufacturing Practices
The degree of our company's quality assurance
oversight attests to the solid commitment to rigor in product lifecycle
management, research, development, manufacturing and distribution. Since
the company's inception, its quality assurance and
control have exceed industry norms and are now all the more visible and relevant
in light of recent recommendations proposed by the FDA.
Our Company's Difference
Quality effectively begins at the product development stage when new
ingredients are first selected: QA has two members on this new product
team - one represents "Supplier Quality Assurance" while the other is
responsible for "specifications." Our company
insists that its suppliers be pre-qualified before they are selected. This
process starts with a "questionnaire" regarding their manufacturing
and testing capabilities as well as their quality control program.
Of particular concern are natural ingredients such as botanicals where
incidences of misidentification and cross contamination with both foreign
materials and harmful chemicals are a potential problem. A QA expert with
compliance auditing experience may be required to visit the growing areas -
their geographical locations - as well as the processing/packaging site to verify
the accuracy of information provided by the potential supplier.
Samples of three different lots of new ingredient will be requested.
These will be tested by our company's chemists and
microbiologists and the results will be used to established our company's
specifications for the material. This might go well beyond the supplier's
own specification, and include requirements which will assure the material's
potency, purity, integrity, and consistency. Only after these quality
standards have been defined, agreed to by the supplier, and documented in the QA
specification is the pre-qualification process considered complete.
Our company requires that each new ingredient
from a new supplier go through this process. A new ingredient from a
previously qualified supplier or an existing ingredient from a new supplier will
undergo similar but less intensive process, but enough to assure that it will
consistently meet our company's high standards.
Scientists and engineers at the company apply
equally rigorous quality assurance principles to the development of a rugged
manufacturing process for each new product. It involves the selection of
appropriate equipment to pulverize, screen, mix, granulate, coat, and compress
tablets or fill capsules, and determine processing times, temperatures, and
Production, packaging, and distribution are also subject to such rigorous
standards of control while our company's product
experience reporting (PER) systems give customers the opportunity to tell the
company where improvements could be made.
New FDA Recommendations
In March 2003, the U.S. Food and Drug Administration (FDA) published a
proposed regulation that would establish current good manufacturing practices
(cGMPs) for dietary ingredients and dietary supplements. FDA intends to
publish the final ruling after a lengthy public comment period. The rule
is intended to reduce the risks of adulteration (contamination) and misbranding
(mislabeling) of dietary ingredients and dietary supplements. Similar
regulations now exist for foods (food cGMPs) and drugs (pharmaceutical
cGMPs). The dietary supplement industry as a whole has so far been
required only to meet food cGMPs that address food safety concerns such as
equipment cleaning, worker hygiene, and plant sanitation. Pharmaceutical
cGMPs incorporate these food safety aspects but also require companies to prove
a product's identity, strength, quality, and purity. This is achieved
through rigorous testing, controlled manufacturing, and detailed documentation.
Consumers of our company's dietary supplements
and food products will already be familiar with the more stringent of these
regulations, pharmaceutical cGMPs, because many aspects of these have been a
part of our company's standard practice for
years. Our company's consumers are proud of
the fact that it tests its products at every step of the manufacturing process,
ensuring the consistent production of safe and pure dietary supplements.
Nutrition 4 Health
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