Natural Nutrition 4 Health
Authorized Shaklee Products Distributor
(502) 225-8245

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Our "Difference" in Good Manufacturing Practices

 

Introduction

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 mixing speeds.

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.

Good Manufacturing Practices

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Good Manufacturing Practices

High Quality Products

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