The Medicines and Healthcare Regulatory Agency (MHRA) has issued Alliance Medical Products (AMP) a good manufacturing practice (GMP) certificate following an audit of the Irvine, California sterile manufacturing facility in December 2010.
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The certificate covers sterile liquids, solids, devices and implants manufactured in any of AMP’s eight aseptic suites and ancillary manufacturing suites.
AMP 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 president and CEO Juan Valdes said the recent certification by the MHRA further demonstrates AMP’s commitment to maintain quality and manufacturing systems to the highest global standards.
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