At Prather Ranch, we are dedicated to supplying the highest quality bovine materials to the Life Sciences industries. We prioritize complete customer satisfaction by ensuring that our products meet the Domestic and International Regulatory requirements for bovine source tissue. Our Quality System is designed to meet the regulatory requirements set forth by the FDA and USDA.
Prather Ranch follows ISO 22442-2, the standard for the manufacture of medical devices using animal tissues and their derivatives. Our Quality System is comprehensive and designed to meet the unique requirements of the pharmaceutical and medical industries.
We have maintained a Closed Herd on the maternal side since 1975, and have redundant closed cattle herds to ensure continuity of supply. In order to safeguard the cattle herd, in 1992, a backup closed herd was developed. The backup herd is managed under the same protocols as the primary herd. Our animal lineage database is extensive and updated regularly. We also conduct onsite USDA Ante and Post Mortem Inspection to ensure that our animals are healthy and meet regulatory requirements.
Material traceability is of utmost importance to us. Our Quality System includes internal and third-party auditing, onsite documentation control, and fully documented employee training. Incoming Material Specifications and Control of Incoming Materials are strictly enforced. Standard Operating Procedures (SOP’s) are established and followed to ensure consistency and quality. Our processes are compliant with current Good Manufacturing Practices (cGMP), and we maintain document revision control to ensure that we always operate according to the most current standards.
We have validated shipping protocols and an established corrective action plan to handle any issues that may arise. Our commitment to quality is unwavering, and we strive to provide the highest quality medical grade bovine material, including pharmaceutical grade bovine collagen-rich corium.
Prather Ranch’s commitment to quality is demonstrated through our compliance with FDA and USDA requirements, ANSI/AAMI/ISO 22442-2 adherence, and the GMP standard. Our closed herd system, animal lineage database, onsite inspections, and comprehensive Quality System ensure that our customers receive pharmaceutical and medical grade bovine materials that meet the highest standards of quality and safety.
