Quality Product Manufacturing
Since its inception, ArthroDynamic has instituted quality sourcing, thorough pretesting of ingredients, and stringent finished product release specifications to ensure that its marketed products meet or exceed industry standards. Product quality always begins with the corporate culture. ArthroDynamic was formed by a number of veterinary practitioners who were seeking new, safe and effective products to use within their own equine practices.
Contract Manufacturing Facilities
ArthroDynamic uses two contract manufacturing organizations (CMO) in the USA to manufacture its injectable products. This provides a greater assurance of product availability at all times. Both CMOs are routinely audited by the FDA for GMP compliance in their manufacturing processes. The CMOs use pre-tested, high quality excipients and sterile water for injection that meets United States Pharmacopeia (USP) standards in formulating our products. These facilities make products for a number of other veterinary and human health companies. All of our packaging components such as, actives, vials, stoppers, labels, and cartons conform to pharmaceutical standards and are pre-approved prior to their inclusion in manufacturing.
Polyglycan®, for example, is manufactured to stringent pre-approved written instructions, where each step of the manufacturing process is performed, monitored, and documented by highly skilled technical and quality assurance staff.
Each vial of finished product is diligently inspected for any defects prior to labeling. Random samples are removed from each production batch and are subjected to numerous critical quality tests, such as sterility, potency, pH, and endotoxins. These tests are performed by the internal quality control department at the CMOs and by an independent testing laboratory, not by ArthroDynamic Technologies. This ensures arm’s length Quality Control is built into the process. Product is released into the market only upon confirmation that all tests have met predetermined specifications.