Quality Assurance

Your finished product is only as good as your testing capabilities can prove it to be.

cGMP

Our full-service cGMP manufacturing facility is certified under 21 CRF Part III. We are a registered facility with the FDA and are certified by the State of Washington for dietary supplement manufacturing. We would also like to note that our manufacturing facility has been approved in over ten countries for dietary supplement exporting.

Hazard Analysis Program

Our testing protocols are established utilizing an NSF-designed hazard analysis program. Since every raw material has a unique microbial or environmental adulteration hazard (such as radiation), each material also 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 USP and or AHPA recommended standards.

USP Method 1119

We conduct 100% in-house testing using the USP method 1119 near-infrared spectroscopy, a scientific process that employs chemometric models to identify all raw materials. Our reference standards are third-party laboratory-verified, certifying their validity. Our hand-selected primary third-party laboratory holds the international ISO 17025 certificate.

USP Method 1116

Environmental testing for microbiological bioburden hazards is an integral part of the testing program First Priority Manufacturing designed. Introducing 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 First Priority Manufacturing voluntarily, from the pharmaceutical codes. Dietary supplement regulations do not require this, but we believe it is imperative for quality.

Mitigations

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 any ingredient is received it is reviewed and tested for its unique hazard(s).

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.

Raw Materials of vitamin ingredients
Microbological Testing for vitamins
Nutraceutical & Dietary Supplement Industries
Microboloical Testing UPS Method 1116 for Vitamins

First Priority’s procurement team is continually seeking the purest ingredients from the finest suppliers around the globe.

 

Third-Party Laboratories

We have hand-selected our primary third-party laboratory, which holds the coveted international ISO 17025 certificate. We also utilize the expertise of multiple other third-party laboratories as needed. Why is this a priority? Verification that our in-house laboratory is audited is integral to our integrity. We do not just rely on our own laboratory, at times a third-party laboratories expertise is important for these audits.

We are continually advancing our robust testing capabilities to offer you the highest standard of assurance, that exceeds cGMP and the FDA requirements.

 

Laboratory Notebook
Our primary third party laboratory that we have hand selected. This laboratory holds the coveted international ISO 17025 certificate. We also utilize the expertise of multiple other third party laboratories as needed. Why is this a priority? Verification that our in house laboratory is audited is integral to our integrity. We do not just rely on our own laboratory, at times we do not conduct certain tests in house and a third party laboratories expertise is important at these times.
LabSpec 2500 Laboratory Instrumentation for Qualitative and Quantitative Materials Analysis ASD LabSpec line of laboratory instrumentation
SPS 4 Autosampler
The SPS 4 is a next-generation, high-performance autosampler for atomic spectroscopy applications. Designed to meet the needs of high-throughput laboratories requiring a fast, high-capacity (up to 360 samples or 768 microtiter wells), reliable autosampler, it is also small, quiet, easy-to-use and affordable. The SPS 4 is suitable for ultra-trace analysis by ICP-MS and rugged and robust enough for FAAS, MP-AES, and ICP-OES users. Built around an innovative gantry design that supports the mechanical components between two rigid pillars, the SPS 4 provides improved accuracy and precision, high speed, ease of access, and corrosion resistance – all within a footprint that is nearly 40% smaller than other autosamplers in its class.

Microbiological Testing in Our In-House Laboratory

Disintegration Testing in Our In-House Laboratory

First Priority Manufacturing exceeds the FDA and cGMP requirements for laboratory testing for dietary supplements.

We offer all standard testing, which is automatically included with your free quote for your finished product. These include:

  • Identity Testing
  • Potency
  • Heavy Metals (arsenic, cadmium, lead or mercury)
  • Radiation Contamination (if herbal)
  • Biological Burdens (staph, E.coli, salmonella, dangerous spores or economic adulteration)

If you would like more in-depth testing on your nutraceuticals, ask your sales agent about the cost for these add-on services:

  • PROP 65 Compliance
  • Gluten Free Verification
  • Disintegration
  • Assembly and Packaging