Quality Assurance and Quality Control are our top priority at Global Nutrition-Pharmcutical grade and 3rd party testing
At Global Nutrition , no corners are cut when it comes to quality assurance. We provide comprehensive proof – and fully guarantee – that our products are prepared in accordance with the highest standards of manufacturing practice and laboratory quality assurance. Pharmcutical To attain laboratory quality assurance (no easy task), we audit and verify each of our independent laboratories to ensure that they follow scientifically valid analytical methods and ethical lab practices. We also research the scientific validity and reliability of laboratory test methods. As a result, only laboratories that use proper reference standards or scientifically valid testing methods are allowed to test our products. Our goal is maximum clinical effectiveness through proven quality.
There are two keys to producing consistent clinical benefit and value: excellent raw materials and finished product quality. That’s why we have assembled a team of qualified health professionals to formulate our products, and use only bona fide research – including published human and/or animal-based studies – to test them. Our team of health professionals works to ensure that the raw materials we use produce the best clinical outcomes and that our products contain true therapeutic doses of the most beneficial active materials.
Quality assurance and manufacturing practices are far superior to those of other nutritional supplement manufacturers. We exceed the FDA’s cGMP Guidelines for nutritional supplements, which cover authenticity, potency and purity testing of raw materials and finished products, quarantine/release procedures, employee training, cleanliness of the facility, documentation, and other areas. We follow detailed written Standard Operating Procedures (SOP’s) to ensure consistency and safety in every aspect of our manufacturing process.
Independent Testing of Raw Materials for: nothing is made in china
Microbiology
Global Nutrition quarantines all purchased raw materials and independently tests for total aerobic bacterial count, yeast and mold counts, Salmonella species, E. coli, Pseudomonas aeruginosa and Staphylococcus aureus.
Identification, Authenticity and Potency
Our quality assurance department is constantly expanding its knowledge to choose the most reputable labs and scientifically valid testing methods and reference standards. Our raw materials and finished products are tested by highly qualified personnel using appropriate sample preparation, instrumentation, ethical and valid scientific testing methodology and authentic reference standards. When raw materials do not meet our specifications, they are rejected.
Chemical Solvent Residue
Global Nutrition manufacturer independently laboratory tests all raw materials for chemical solvent residue. Many vitamins, minerals, amino acids and botanical products are manufactured using one or more chemicals or chemical solvents. Currently the natural products industry has no limits on chemical or solvent residue allowed in natural products. Global Nutrition complies with USP 467, the pharmaceutical industry’s standard limits for residual chemical solvents.
Heavy Metals
All botanical products are tested for presence of lead, mercury, cadmium, and arsenic. Minerals and other raw materials prone to toxic metal contamination are tested for lead.
Herbicide, Pesticide and Fungicide Residue
Every botanical product we use is tested for residual amounts of a variety of herbicides, pesticides and fungicides. Our independent lab uses methods developed by the California Department of Food and Agriculture (CDFA). The State of California uses these same methods in its enforcement programs to determine the presence of numerous pesticides in a variety of crops. We test for 61 different Organochlorines, 75 Organophosphates and Organonitrogens, 12 Carbamates, and 11 Pyrethroids.
Aflatoxin Residue
The US FDA has set a limit of less than 20ppb for total aflatoxins in food and feed. Every botanical product we buy is tested for residual amounts of aflatoxins and must meet our specification before we allow the material to be used in production.
Independent Testing of Oil Products:
Our lipid softgel products are tested for primary oxidation by-products (peroxide levels) and secondary oxidation by-products (anisidine levels). A high level of either is indicative of rancidity of long chain fatty acids. It is critical to test for both as peroxides are transitory and can drop to a low level as they transform into secondary oxidation by-products (anisidines).
Independent Testing for Dioxins & Dioxin-Like Compounds:
(All Fish Oils) Dioxin is a generic term used to describe a family of 210 compounds. We test for the most dangerous of this family -- the 17 members characterized by the presence of chlorine atoms in the 2, 3, 7, and 8 positions. Each of those 2, 3, 7, 8-substituted congeners has been assigned a Toxic Equivalent Factor (TEF), which is used for the computation of the Toxic Equivalency Quotient (TEQ). This scale is used in risk assessment studies to calculate the probability of causing cancer and other life threatening diseases in humans.
Independent Testing for PCBs:
(All Fish Oils) PCBs (Polychlorinated Biphenyls) are no longer produced in the United States, but are still found in the environment. Health effects that have been associated with exposure to PCBs include acne-like skin conditions in adults and neurobehavioral and immunological changes in children. PCBs are known to cause cancer in animals.
The Department of Health and Human Services (DHHS) has concluded that PCBs may reasonably be anticipated to be carcinogens. The EPA and the International Agency for Research on Cancer (IARC) have determined that PCBs are probably carcinogenic to humans. Global Nutrition minimizes Dioxin and PCB exposure with its parts per trillion assay method and very strict acceptance criteria.
Finished Product Expiration Date & Stability-Testing Program
Global Nutrition manufacturer was the first professional natural product manufacturer to put into place a finished product, expiration date, and stability-testing program. This program provides us with independent laboratory test data points to guarantee that our products meet 100% of label claim and validates our published expiration date.
We publish expiration dates based on third-party test data to support such a date. Our new products are given manufactured dates until we have sufficient data to ensure product stability through the expiration date. However, from our experience and testing, products with manufactured dates may be good for at least twelve months.
To authenticate this dating on an ongoing basis, we put our products through analytical and microbiological tests as well as visual inspections. Independent laboratories test our finished products to ensure label claim potency. We then repeat the tests on a retained sample from the same lot at mid- and end-points of expiration date to check label claim potency.
We also test for rancidity markers on our oil products at each stability test point. Manufactured finished products are routinely tested to authenticate expiration dates.
Our independent lab testing verifies purity, potency, and label claim. At each data point we evaluate the potency of the product to see if we need to add an overage to make up for any deficiency in potency or alter the expiration date. Of course, this is in addition to the testing we do on every batch of raw materials to ensure authenticity, potency, and lack of contamination prior to manufacturing.
Manufacturing Excellence
Global Nutrition manufactures its supplements in a clean, strictly controlled facility. We know precisely what goes into our products, and more importantly we know what is not in our products. This allows us to produce products that are free of unacceptable binders, excipients and other potential allergy-causing or undesirable additives.
The facility is staffed with a full time Quality Assurance and Quality Control Manager and Quality Control personnel to ensure consistent compliance with our industry leading comprehensive quality system and FDA Good Manufacturing Practices. You can depend upon Global Nutrition to provide the finest quality natural products. We assure “proven and verifiable” quality and supply practitioners with clinically effective products and formulas.