Study Raises Questions About Safety of Herbal Supplements
Documented Cases of Toxicity
from Natural Products
What Is Toxicity And How Is It Determined
Natural Product QUALITY ASSURANCE
Quality Verification
Laboratory Testing Procedures & Standards
Dietary Supplement
Health & Education Act of 1994
Antioxidant Supplements
 


QUALITY VERIFICATION / QUALITY ASSURANCE

There are a series of questions one needs to know to ask and the answers that will verify that all the steps are in place to guarantee consistency in quality and purity in the manufacturing of dietary supplements, including vitamins, minerals, herbals, oils, amino acids and their derivatives. These questions are:

  • Does the company follow current Good Manufacturing Practices (cGMP's)? If so, is it food, over the counter (OTC), or pharmaceutical cGMP's?
  • Does the company have a cGMP compliance audit procedure? Has the company been independently audited to verify its compliance with cGMP's? If so, who did the audit? Is a copy of the audit available?
  • Does the company have an in-house Quality Assurance/Quality Management (QA/QM) program? If yes, what is the staff size and qualifications? To whom does QA report?
  • Does the company have an internal audit process?
  • Are all raw materials quarantined before Quality Assurance releases them?
  • Does the company have a label management program?
  • Does the company have a formal training program for employees? If so, is it documented?
  • Does the company have written Standard Operating Procedures (SOP's) that cover manufacturing, quality control, sanitation, material procurement, etc.? Does the QA/QM department ensure compliance with the SOP's?

The current Good Manufacturing Practices (cGMP's) cover identity, authenticity, and potency testing of raw materials and finished products, quarantine release procedures, employee training, cleanliness of facility, documentation, and the following of detailed written SOP's to ensure consistency and safety in every aspect of the manufacturing process.

Independent auditing and certification of natural product manufacturing quality assurance proves compliance with cGMP guidelines and quality assurance practices. Two third party organizations that are leaders in auditing and certification in this industry are the National Nutrition Foods Association (NNFA) and the National Science Foundation (NSF).

  • ViTAL NUTRIENTS is the only professional natural product manufacturing company that is audited and certified for cGMP's by both the NNFA and the NSF.
  • ViTAL NUTRIENTS meets or in many cases exceeds United States Pharmacopoeia (USP) standards, and the proposed Food and Drug Administration (FDA) cGMP's for nutritional supplements.
  • ViTAL NUTRIENTS follows detailed written SOP's to ensure consistency and safety in every aspect of our manufacturing process.
  • ViTAL NUTRIENTS uses the highest standards for Quality Assurance/Quality Management. A detailed outline of their QA/QM follows below.

At ViTAL NUTRIENTS the raw materials and finished products are always independently tested by laboratories that use proper reference standards and scientifically valid testing methods.

ViTAL NUTRIENTS is happy to provide a more detailed explanation of laboratory policies and procedures if one has an interest in learning more. (Go to Laboratory Testing Procedures and Standards, #7, under Are You Taking Dietary Supplements?)

At ViTAL NUTRIENTS raw materials are always tested for:

  • Microbiology Contamination - total aerobic count, yeast & mold counts, Salmonella species, E. coli, pseudomonas aeruginosa and staphylococcus aureus.
  • Authenticity - via Thin Layer Chromatography, HPLC, or microscopy identification.
  • Potency - assay by HPLC, GC or appropriate scientifically valid test method.
  • Heavy Metals - lead, mercury, cadmium, arsenic, and aluminum to the parts per billion (ppb) level on all botanical products, fish oil, minerals, and other raw materials prone to toxic metal contamination.
  • Single or Multiple Chemical Solvent Residue - tested by Gas Chromatography &Mass Spectroscopy to limits for the pharmaceutical industry. Currently there are no limits for the natural product industry and many vitamins, minerals, amino acids, and botanical products are manufactured using chemicals or chemical solvents.
  • Peroxides & Anisidines - primary and secondary oxidative byproducts, which are markers for rancidity in, oil products.
  • Herbicide, Pesticide, and Fungicide Residue on all botanicals - a panel of 136 chemicals.
  • 17 Dioxins and Dioxin like Compounds to the part per trillion (ppt) level - these are the ones with the chlorine atom in the 2,3,7,and 8 positions and have been assigned a toxic equivalent factor used to compute the toxic equivalency quotient determining the probability of causing cancer and other life threatening diseases in humans.
  • 14 PCB's (polychlorinated biphenyls) to the ppt level - the strictest acceptance criteria as the Department of Health and Human Services (DHHS) has concluded that PCB's may reasonably be anticipated to be carcinogens and the Environmental Protection Agency (EPA) and the International Agency for Research on Cancer (IARC) have determined that PCB's are probably carcinogenic to humans. No longer produced in the US, they are still in the environment.

At ViTAL NUTRIENTS finished products are always tested for:

  • Label Claim Potency - Assay by HPLC, GC, or appropriate scientifically valid test method.
  • Microbiology Contamination - bacteria, yeast, and/or mold contamination that may occur in the encapsulating process.

At ViTAL NUTRIENTS all products are independently laboratory tested for:

  • Stability Profile &
  • Expiration Date Validation

•  Stability assay at 12 months to insure potency

•  Stability assay at 24 months to insure potency

•  Microbiology contamination by bacteria, yeast, and/or mold during shelf life.

Samples from the first three lots of each product are kept shelved in seclusion for testing. Independent certified laboratories test the finished products after manufacturing and then repeat the tests on the retained products samples from the same lot at 12 and 24 months.

At ViTAL NUTRIENTS the products are Doctor/Pharmacist formulated and are not manufactured by an outside contractor. They know precisely what goes into their products and most importantly what is not in the capsule. All ViTAL NUTRIENTS products are encapsulated. This allows for production of products that are free of unacceptable binders, excipients and other potentially allergy causing or undesirable additives.

At ViTAL NUTRIENTS there is a full time Quality Assurance and Quality Control Manager who has a Masters of Science in Chemistry and is a ISO 9000:2000 certified quality assurance auditor.

This Information was developed from the specifications listed on the

ViTAL NUTRIENTS website:

www.vitalnutrients.net

 

Quality Assurance: how to ask the right questions - click here