cGMP – Why It’s Important to You
ICA Health complies with the set of standards known as current good manufacturing practice (cGMP) established for the dietary supplement industry and regulated by the United States Food and Drug Administration (FDA). We are independently certified to be cGMP compliant.
These regulations ensure the identity, purity, strength, composition and quality of dietary supplements. They require that manufacturers and vendors comply with specific procedures and standards in documentation, personnel qualifications, training, sanitation, cleanliness, testing, equipment verification, process validation, and complaint handling to ensure that each product is safe, pure, and effective. Raw material suppliers are also regulated for standards in identity, purity and testing of all raw material ingredients.
Some areas for which there are required cGMP standards to meet:
- Quality Control
- Identity Testing
- Contaminant Testing
- Labeling Regulations
- Sanitation and Facility Management
- Operating Procedures
A Special Word about Finished Product Testing
Each batch of finished product is tested to make sure it is free of contaminates and meets consistency specifications; however it is not possible to test and confirm the actual amounts of all the ingredients in a multi-nutrient supplement. This is because in the analytical testing processes the product must be liquefied. The liquefaction causes the ingredients to start reacting with one another, bringing about changes in the structure and/or weight of certain ingredients and, in some cases, creating new substances. These changes make it impossible to accurately measure every ingredient.
Doctor Wilson’s Original Formulations supplements are subjected to the most reliable method for ensuring all ingredients are present in the correct quantities:
• confirmation of the purity and potency of the raw materials
• validation of the protocols followed during the manufacturing process
We never sacrifice on quality, safety OR results. Many of the things we do to produce our supplements go beyond government requirements. We use our expertise to incorporate the extras that can maximize a product’s effectiveness and safety – from the science and clinical experience that go into the original formulas, to the choice of superior ingredients, to the way the ingredients are processed and combined, to the conditions in which they are manufactured. We care about providing the best that we can offer. Below are some important things to know about our company’s efforts to produce the best products.
The Doctor Wilson’s Original Formulations supplements were created by Dr. James L. Wilson who, in addition to having thirty years of clinical experience and twenty years of formulating dietary supplements, has a Ph.D. in Human Nutrition with minors in Immunology, Microbiology, Pharmacology and Toxicology, and research focus in Cellular Immunology. His inspiration for these formulas comes from working with many patients who had unsuccessfully sought help from a number of other medical or naturopathic doctors. He combines his research and science background with extensive clinical experience to formulate products that are exceptionally clinically effective and scientifically supported. The difference is expressed in our motto, “Results are the most important ingredients in our products.”
The raw ingredients for the Doctor Wilson’s Original Formulations supplements come from only the most reputable suppliers who guarantee their purity. Each supplier sends a Certificate of Analysis with every shipment of ingredients showing that these raw ingredients have been tested and successfully passed standards of purity and quality set by the US government. In many cases these raw ingredients far surpass government requirements. Dr. Wilson works with the manufacturers and suppliers to procure the raw materials with the highest levels of bioactive components that will provide the most effective results. Wherever possible, the Doctor Wilson’s Original Formulations supplements use organically grown botanicals and source nutrients. The formulating priority for Doctor Wilson’s Original Formulations supplements is to make sure they promote optimum health and work in harmony with the body.
We do not use synthetic fillers or coatings, or artificial sweeteners, flavors, dyes or preservatives. Excipients and fillers (rice powder) are used minimally and only where necessary.
All but three of our products are vegetarian. These vegetarian formulas are completely free of animal substances (vegan). For the encapsulated products we use the highest quality, new generation capsules made from vegetable cellulose. They are more resistant to breaking in the bottle, yet disintegrate more readily once ingested. This means optimum ingredient availability and value.
Our three non-vegetarian products – Adrenal Rebuilder®; Adrenal POWER Powder™; and Hair, Skin and Nails Plus Formula™ – are also exceptional products. Adrenal Rebuilder and Adrenal POWER Powder contain porcine glandular extracts. The single non-vegetarian ingredient in Hair, Skin and Nails Plus Formula is gelatin. The select, high quality animal source ingredients in these products are essential to their effectiveness and compatibility with the body’s restorative processes.
Glandular Extract Concentrates
All of our glandular extracts come from pigs. Obtaining these extracts from a porcine (pig) rather than bovine (cow) source eliminates concerns about prions or BSE (mad cow disease) because there are no known porcine sources of prions. The glandulars come directly from animals inspected by independent veterinarians and raised for food consumption without chemicals, antibiotics, growth hormones, pellet food, forced feeding, overcrowding, or any of the other inhumane methods often associated with commercial animal husbandry. All of the glandular extracts we use are processed to remove hormones but retain the important nutritive components that are effective building blocks for health.
Wherever possible the botanical ingredients we use come from non-irradiated, organically grown (without synthetic fertilizers, herbicides or insecticides) or wild-crafted (picked in the wild) herbs and plants harvested at peak condition. Plants grown and harvested in this manner are superior to standard sources in quality and active properties. Although this can be much more costly for us, we believe it is important to use the most clinically effective sources for all of our ingredients.
We typically use pharmaceutical (USP) grade vitamins and minerals for maximum quality. USP sets recognized standards for vitamins and minerals to help to ensure their quality, purity, strength, and bioavailability. USP grade assures over 99.4% purity and is considered to be superior to US food grade.
Wherever it is appropriate to enhance bioavailability, we use fully reacted mineral compounds rather than blended or partially reacted mineral compounds. Fully reacted mineral compounds are considerably more expensive but provide the specified mineral in a form that is much easier for the body to absorb and utilize, and they ensure that the minerals are reliably present in the desired amounts. We never use low grade mineral forms like oxalates that appear high on the label but have such low bioavailability that the body gets very little benefit from them. For example, in magnesium oxalate, the magnesium binds with oxalic acid so tightly that the body cannot absorb or utilize more than a small percentage of it.
The manufacturers of Doctor Wilson’s Original Formulations supplements are also cGMP certified. After procuring the highest quality, guaranteed pure, raw materials with Certificates of Analysis, the specially trained manufacturing staff takes great care in ensuring that every step and procedure in the manufacturing process is carefully monitored and subjected to a number of quality checks, including:
1. The raw ingredients are quarantined in a climate controlled, sanitary environment until all necessary testing is completed. These tests include visual inspection, analysis for microbial (bacteria, mold, yeasts) and other contaminates, and potency testing to compare the levels of the active substances (vitamins, minerals, botanicals) with those stated in their Certificates of Analysis.
2. Once released from quarantine, the ingredients are processed in a sanitary, climate controlled environment. At least two people independently sign off each ingredient as it is added to the product. Periodic quality checks are carried out by the Quality Control Department to make sure tablet or liquid consistency meets specifications.
3. Each batch of finished product undergoes further in-house and independent inspection and testing to ensure it is free of contaminants, and meets consistency specifications.
cGMP certification requires manufacturers to adhere to strict sanitation and sterilization standards, which are monitored through Quality Control Departments that are trained specifically to ensure the cleanliness and sanitation of all equipment and overall manufacturing procedures. They must keep accurate records showing the origins and Certificates of Analysis of all raw materials. The manufacturing facilities have to pass government inspection for sanitary storage of raw material, cleanliness and proper record keeping.