Science and quality are at the center of what we do at CTPharma. We have a rigorous pharmaceutical-based quality assurance program that complies with the requirements of the FDA’s current Good Manufacturing Practices (cGMPs). This means that all processes and testing are documented and reviewed to assure process control. For example, batch records are completed for every lot of soil that we blend to make sure that the necessary recipe is always followed. This assures us that the plants that are grown from that particular soil blend will likely always meet the requirements for batch to batch consistency.
Quality Control (QC) is similar to quality assurance except that it is the laboratory testing portion of the cGMP requirement. So for example, whenever we formulate a compost tea, quality control sampling and testing verifies that the tea meets all of the necessary requirements to assure the plants are receiving the nutrition that they need. We apply the same QC testing requirements to our incoming raw materials intermediate product testing, and to the finished product testing.
We use Northeast Laboratories for all of our third party testing needs. They are a Connecticut based testing laboratory located in Berlin that has been in business for over forty years. They are licensed to test not only cannabis, but also DEEP, DEA, FDA, and other federally regulated testing needs. All of their laboratory equipment meets ICH and FDA requirements for calibration and validation, and their scientists must meet annual proficiency standards. This assures us that our testing laboratory is providing us with accurate results for the products and services they provide us with. We use Northeast Laboratory for product release testing, environmental monitoring of our facility, and for stability testing of our products.
Stability testing is how we determine the expiration date that is indicated on the label of every product that we offer. How we do it is to take several units from a released lot of product, and then place them in a controlled room temperature incubator, and a controlled freezer chamber. Then at one month, three months, six months and a year, the product is tested to evaluate what happens to the cannabinoid content over the course of time, and at different storage conditions. We do this to assure that the product continues to reliably and predictably meet label claim for potency and expiration.