Freedom is made in a contract CGMP manufacturing facility certified under 21 CRF Part III. This facility is registered with the FDA and certified by the State of Washington for dietary supplement manufacturing.
All processing and manufacturing is done in isolated production rooms (clean-rooms) to prevent any cross contamination of ingredients and products. Before and after each production run the production rooms are cleaned and sanitized to prevent cross-contamination, however the manufacturing facility does process gluten at times. Contact us if you need to know more about this.
We designed our testing protocol using a NSF 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 USP and or AHPA recommended standards.
- We require 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. Our hand selected third-party laboratory holds the international ISO 17025 certificate.
- 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 our manufacturer. 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 voluntarily, from the FDA’s pharmaceutical codes. Dietary supplement regulations do not require this, but we believe it is imperative for quality.
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 our purity standards.