Our testing protocols are established utilizing a NSF-designed hazard analysis program. Since every raw material has a unique microbial or environmental adulteration hazard (such as radiation), each material has a predetermined testing protocol suited to its own risk level. Regardless of how low the risk level is determined to be, every raw material is tested using the USP and AHPA recommended standards.
Priority One guarantees that all our botanicals are radiation-free. Unlike many of our competitors, we have a standard monitoring program to insure that no radiation is used in the sterilization of our botanicals. When sterilization is needed, we use a dry-steam technology or other non-destructive technologies.
• We conduct 100% testing using USP method 1119 Near-Infrared spectroscopy, a scientific process that uses chemometric models to identify all raw materials. Our reference standards are third-party laboratory-verified, certifying their validity. We have also developed a program utilizing spectroscopy USP method 1119 to establish chemometric models of finished products. These testing models are then used to assure that products meet all intended identity, strength, and composition specifications unique to each finished product batch. Finally, every finished batch is tested again for microbial adulteration, thus assuring that every batch meets the highest purity standards.
• We conduct regular audits of our outside laboratory partners and qualify their results eliminating “dry labbing” dangers.
• Environmental testing for microbiological bio-burden hazards is an integral part of the testing program designed by Priority One. Introduction of microbial adulterants during holding or processing is monitored utilizing USP Method 1116 for continued evaluation of microbial limits in controlled areas. This method was adopted by Priority One voluntarily, from the pharmaceutical codes. Dietary supplement regulations do not require this, but we believe it is imperative for quality.
• Each finished product is tested again for microbial adulteration as well as the heavy metals; arsenic, cadmium, lead, and mercury. This is done by our hand selected primary third party laboratory. This laboratory holds the coveted international ISO 17025 certificate. These important steps assure that our products meet the highest purity standards.
Hazard Analysis & Mitigations
Priority One maintains a robust hazard analysis program that reviews the potential for risks associated with each manufacturer of ingredients following NSF guidelines.
First, four members of our quality team review the quality program of a potential vendor, utilizing physical audits, interviews, testing method validations, and background checks for past or current regulatory issues.
Next, all compiled information is brought to a classification session. During this session, a review of the documents and ingredients supplied by the potential vendor is conducted. Potential hazards are proposed such as country of origin, economical adulteration potentials, or recent environmental changes to name just a few.
After all potential hazards have been agreed upon and classified, the probability of such hazards occurring is determined, using a classification from frequent (1 in 5 purchases) all the way down to extremely unlikely ( 1 in 10,000 purchases). These are determined by scientific methods, observations, real-life testing protocols, and industry inside knowledge of economically generated adulterations. Last, using the severity and probability, a risk level is determined.
Our ingredient mitigations are then determined by risk level. Mitigations describe how a risk level is reduced by the design of our quality systems. Immediate precautions are designed to block hazards in normal conditions. Also included in these mitigations are at least one upstream and one downstream protection to block the hazard from entering the processing chain. These mitigations are ingredient-specific and are added to each ingredient specification sheet, assuring that each time that ingredient is received it is reviewed and tested for its unique hazard(s).
All ingredients have risks and require systems to block sources of containments. We do not rely on the supplier for your patient’s safety. Risks such as radiation contamination, heavy metals, E. coli, salmonella, staph, dangerous spores, and economic adulteration are monitored by our rigorous testing methodology. By identifying such risks ahead of time, the mitigation process enables us to block these hazards.
In compliance with current CGMP labeling guidelines Priority One has developed a quality assurance labeling team that continually monitors our labels to assure accuracy and full disclosure of all ingredients. Our full disclosure labels give you the confidence that there are no hidden ingredients in our products.
CGMP labeling guidelines require all components, including the starting materials of minerals and any excipents from the extraction and standardization process of botanicals to be listed.
• In minerals the starting component is listed along
with the chelated element.
For example many supplements simply list Calcium (chelate). Our full disclosure labels show you the starting component and as well as the chelated element. In the case of our Effervescent Cal-Mag it looks like this: Calcium (as calcium citrate hydroxide carbonate) The carbonate is the mineral in raw mineral form.
• If an excipient is used in the raw material process
ing of botanical extracts these will be listed.
Our Quality Control department monitors raw materials for all composition ingredients.
Priority One is at the forefront of full label disclosures. Our labels are printed to match an individul lot number and product run. You can have full confidence that if it is in the product it will be listed on the label.
Do you know where your glandulars are coming from? Do they contain antibiotics, hormones, pesticides or heavy metals?
Glandular supplementation has a long and safe history of effective use by medical professionals. As with all the dietary supplement ingredients we source for our products quality and purity are top priorities. Therefore, our primary glandular source is Denmark. Denmark has been antibiotic and growth-hormone free for all bovine and porcine glands since 1998. This means that glands sourced from Denmark are pure, untreated, and retain the best balance of naturally occurring hormones available.
When necessary due to supply shortage, unavailability and other factors present in sourcing ingredients from around the world, we utilize our rigorous testing methodology to procure ingredients that meet the highest standards of purity. An example of this is our thyroid supplements. We currently source our thyroid from New Zealand.
Not all glandular sources are equal. That is why we go to great lengths to procure the finest glands available. Sources like Denmark with one of the most robust quality control systems in the world and pristine places like New Zealand and Argentina. Both renowned for their impeccable quality in glandular products.