Bio-Matrix Scientific Group is entering the facility validation process arena. Working with company’s chief scientific advisor, Geoffrey O’Neill, Ph.D., Bio-Matrix will develop its facility validation protocols. These protocols form an integral part of Bio-Matrix’ Quality System that will comprise its overall Good Manufacturing and Good Tissue Practices (cGMP/cGTP), according to Dr. O’Neill.
“The management of Bio-Matrix has already developed the essential elements of its Quality System, including areas such as its quality policy, management responsibility, and quality assessments,” he says. “The validation process will specifically address procedures to ensure that all equipment and processes provide a quality product and that personnel are trained accordingly. Standard procedures will be developed for medical device production as well as for cellular processing and storage.”
“The installation, operational, and performance qualification (IQ/OQ) of equipment, systems, facilities, and processes for cryogenics, processing, labs, and medical devices are an essential part of the validation process,” adds David Koos, chairman of the company. “Equipment must be installed, operated, and maintained within design specifications, while processes must be shown to be reliable, all of which to assure the consistent quality and integrity of the product.”
According to the company’s COO, Brian Pockett, key staff must provide a basic and thorough understanding in preparing, executing, and reviewing protocols. “Management has the responsibility for approving and implements these protocols within the framework of its overall quality system,” notes Pockett.
Once protocols are completed, all Quality Systems documentation will be warehoused in the company’s Regulatory Affairs Department within the facility.
Bio-Matrix’ new 15,000-sq-ft facility is located in the San Diego biotechnology corridor and will house Bio-Matrix’s secure Cryogenic Stem Cell Bank, 3 Research laboratories, aseptic cellular/tissue class 10,000/100 processing laboratory, hematology, microbiology, and flow cytometry laboratories.