Good Manufacturing Practices help our company ensure that we provide a quality product each and every time. The FDA, USDA and state CDHPE generally look for such systems to be in place in any facility that provides natural products to foods, supplements, or pharmaceuticals.
We use operating procedures within our cGMP guidelines to standardize all operational functions of the business. This starts with specific personnel training to include: safety compliance standards of operation, sanitation and environmental control procedures and standards, material handling and production procedures, quality control testing at each step of the process, and quality compliance verification to follow behind everything and everyone.
By having such defined and measurable parameters in place, we can achieve highly precise replication of each process and product that we provide.
In addition, we follow Good Laboratory Practices to ensure that off of our processes used for testing, analysis, qualification, research and quality control are strictly regulated by a measurable and logic-based set of regulatory guidelines set forth by the FDA. This rigorous framework of standards and protocols guides our laboratory conduct in a local, reasonable, and unbiased direction. This important step keeps all parts of the process straightforward and reliable.
Good Agricultural Practices guide and govern the land we use, the way we use it, and how the crops are treated, handled, and cared for while under our management. This set of guidelines and operating principles are key to achieving consistent and reliable production on a commercial scale.
During the entire process of land preparation, farming and harvest, there are strict procedures, based on guidance by the FDA, for internal auditing conducted in congruence with daily compliance checks to ensure strict adhesion to the operating procedures. These standards are not absolute requirements, but they serve as an important benchmark, one that is used by almost all true commercial food producers, to achieve quality, consistency, and to gain consumer confidence.
We only grow on farmland that is qualified as Certified Organic based on the current standards set forth by the USDA. The Land is prepared by strict standards and only treated with Certified Organic supplements. Furthermore, using all organic supplementation, ensures that the field and facilities are kept extremely sanitary, which is paramount in our overall operations towards GAP compliance.
The water being pumped from our wells is tested on a continuous basis to ensure that any fluctuation in quality or profile of the water can be compensated for or adjusted within specification, as needed. To rectify out-of-spec water, we use any number of various strategies, including reverse osmosis, filtration, and/or mineral sequestrations or additions. All nutrients utilized conform to USDA Organic Standards. As an additional quality measure, nutrients are quarantined and tested prior to use, and are only utilized when they prove to be consistent with guidelines previously established by the FDA.
Pest management on our farms rely on the ‘PAMS’ strategy: prevention, avoidance, monitoring and suppression. Prevention and avoidance are the first line of defense against pests, weeds, and diseases. If pest or weed suppression becomes necessary, producers often use mechanical and physical practices, such as releasing predatory insects to reduce pest populations or laying down a thick layer of mulch to smother weeds.
We utilize professionally designed, custom harvesting, handling and storage equipment to guarantee the crops to be handled with little to no human contact, reducing greatly, contamination. All process surfaces and contact parts on equipment are cleaned, sanitized, and maintained according to our strict sanitization procedures guided by the FDA’s cGMP guidelines. The storage facilities for these crops are also built to comply with these standards, thus we have specialized systems for the reduction of pathogenic agents installed to function continuously. If contamination is ever found in any holding area, the entire crop must be quarantined for an extended time to determine if any of the crop can be utilized.