How are our products manufactured?
Certificates of Analysis are issued on every batch of our Herbal Fortress products for Quaility Assurance –
Materials (Ingredients, excipients, capsules, packaging materials)
All incoming raw materials are tested and or examined for identification. Every raw material has unique microbial adulteration hazards; these hazards are identified through our Hazard Analysis program, and then materials are individually tested for such hazards. These are identified on each ingredient specification sheet. Using the risk level of the hazard(s), the Quality Control department may utilize all testing methods listed above, but regardless of how low the risk level may be; each material will be tested for a minimum of two unique microbial adulterants as to USP and or AHPA recommended standards.
Environmental Testing Protocols:
Environmental testing for microbiological bio-burden hazards is an integral part of the testing program designed by First Priority. Introduction of microbial adulterants during holding or processing is monitored utilizing USP Method 1116 for continued evaluation of microbial limits in controlled areas.
Designated processing areas, equipment and surfaces within have been identified for monitoring; in addition to these areas, the workforce member conducting the test will sample personnel garments, gloves, and microbial contents of room air, and compressed air in controlled environments. Workforce members involved in processes in these areas being sampled will be identified during the sampling process to monitor trends tied to personnel, and better enable specific training to be conducted when addressing microbial levels to ensure that the highest purity levels possible are maintained.
Herbal Fortress environmental testing protocols are above the nutritional industry standard, and have been voluntarily enacted to insure the purity of all finished products. You will see the USP Method 1116 utilized in all pharmaceutical facilities in the United States.
Finished Product Testing Protocols:
To ensure that all finished products released by Herbal Fortress meet our stringent standards we tests random samples of each finished sealed batch and conduct additional microbial testing before it is released. This is to ensure that everything that touches the product, bottle, lids, cotton, seals, or other packaging materials adhere to these high standards. These test results may be provided to each of our clients with their finished product upon request.
Identification, Strength, and Composition
Herbal Fortress maintains a policy of a strict chain of custody for all batches. This chain of custody starts with a 100% identification process of all incoming materials, each material is also tested to ensure that it is within specifications for strength. FPM utilizes USP method 1119 Near-Infrared spectroscopy, a scientific process that uses Chemometrics models. Our reference standards are third party laboratory verified certifying their scientific validity.
Continuing this chain of custody our Quality Control agents perform composition checks throughout the process of each batch at designated critical points to ensure specifications are met. No less than twelve critical points are evaluated before the finished batch is reviewed for final release to Quality Assurance, who then attests that the Quality Control department has conducted all tests, and approves or rejects the final quality of the finished batch. The composition of each finished batch is reviewed by our Quality Team, to ensure that each step, phase, and specification that was established on the master batch record has been accomplished, and indeed meets those predetermined standards.
Furthermore, we have developed a program utilizing spectroscopy USP method 1119 to establish Chemometrics models of the finished released product. These models are then used to assure that products meet all intended identity and strength specifications unique to each finished product batch as specified by our clientele.
Utilizing these methods, each finished product is assured to meet or exceed 21 CFR Part 111 Dietary Supplement regulations.