07.17.08
HollisterStier Contract Manufacturing received its certificate of GMP compliance by the Medicines and Healthcare Products Regulatory Agency (MHRA). This certification was issued following an inspection of the company's facilities, quality systems and processes and includes the manufacture of Investigational Medicinal Products for clinical trials, as well as the a terminally sterilized diluent on its new Small Volume Parenterals Line (SVP II).
The new SVP II line at the company's 172,000-sq.-ft. facility is available to aseptically fill liquid and lyophilized pharmaceutical products in vials ranging from 2mL through 200 mL in batch sizes from 20 to 3,000 liters. A recent routine GMP inspection also concluded with no inspection observations being issued for the new SVP II line.
“HollisterStier is pleased that our facility has received MHRA certification and a positive inspection from the FDA,” said Rick Lapointe, president of HollisterStier Contract Manufacturing Business Unit. “We dedicate ourselves to ensuring our manufacturing processes operate at an exemplary level — this level of acknowledgement is something in which we’re all very proud.”
The new SVP II line at the company's 172,000-sq.-ft. facility is available to aseptically fill liquid and lyophilized pharmaceutical products in vials ranging from 2mL through 200 mL in batch sizes from 20 to 3,000 liters. A recent routine GMP inspection also concluded with no inspection observations being issued for the new SVP II line.
“HollisterStier is pleased that our facility has received MHRA certification and a positive inspection from the FDA,” said Rick Lapointe, president of HollisterStier Contract Manufacturing Business Unit. “We dedicate ourselves to ensuring our manufacturing processes operate at an exemplary level — this level of acknowledgement is something in which we’re all very proud.”
