GRAM Attains EU GMP Certification for Commercial Aseptic Fill/Finish

Grand River Aseptic Manufacturing (GRAM), an injectable CDMO, was recently audited by the Dutch Health and Youth Care Inspectorate (IGJ) and issued EU Good Manufacturing Practices (EU GMP) certificate. This recognizes that GRAM's manufacturing facility and processes are in compliance with GMP requirements and highlights GRAM's readiness to provide commercial aseptic fill/finish services in the European market. The certification was granted after virtual inspection in January 2021. 

"GRAM is well-known for safely and reliably producing life-saving injectable drug products, and we are delighted to be able to bring our commitment to manufacturing quality pharmaceutical products to the European market," said Colleen Herczak, Vice President of Quality at GRAM. "We strongly believe in responsible growth and are incredibly fortunate to now have the increased ability to broaden our impact and make a difference in even more people's lives.

In 2020, GRAM opened a new 60,000 sq. ft. large-scale fill/finish facility with state-of-the-art, advanced technology from Bausch+Ströbel and SKAN. This year, GRAM made further investments in new equipment from the European vendors to meet increased customer demand, which included an additional Bausch+Ströbel vial filler with SKAN isolator and a new VarioSys syringe and vial filler.

GRAM will continue its expansion by opening a new finishing center near downtown Grand Rapids in Spring 2021.