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.”
