IRVINE, Calif.--(BUSINESS WIRE)--ALLIANCE MEDICAL PRODUCTS ("AMP”) announced today the Medicines and Healthcare Regulatory Agency (MHRA) has issued a Good Manufacturing Practice (GMP) Certificate following an audit of the manufacturing site conducted in December 2010. The certificate covers sterile liquids, solids, devices and implants manufactured in any of AMP’s eight aseptic suites and ancillary manufacturing suites.
"We are extremely pleased with the results of the recent audits of our Irvine, California sterile manufacturing facility,” said Juan Valdes, President and CEO. “We have an excellent history of successful audits with regulatory agencies on the state, national and international level. The recent certification by the MHRA further demonstrates AMP’s commitment to maintain our quality and manufacturing systems to the highest global standards."
The MHRA is an Executive Agency of the UK Department of Health, responsible for ensuring the safety, quality and efficacy of medical devices and pharmaceutical products. MHRA experts assess all applications to ensure they meet the required standards and follow up with a system of inspection, testing and safety monitoring.
ALLIANCE MEDICAL PRODUCTS, INC. is a full service cGMP, FDA, MHRA and ISO13485 drug, device and combination product contract manufacturer providing developmental, clinical and commercial contract manufacturing services to large and small organizations. AMP specializes in difficult to manufacture formulations that include solutions, suspensions, emulsions, sterile ointments and gels with the capability to fill an array of container closures including; vials, dropper tip bottles, screw cap bottles, cartridges and tubes. AMP has extensive manufacturing capabilities which include five high volume automated aseptic filling suites and three semi-automated low volume aseptic filling suites. In addition to its manufacturing capabilities, AMP maintains state of the art micro and analytical laboratories, and the capability to provide stability services meeting all ICH guidelines.
If you’d like more information about AMP, or to schedule a meeting, please contact Steve Tulk at 949-454-4582 or email Steve at pr@amp-us.com.