INSIGHTS ON PHARMACEUTICAL INSPECTION

PHARMACEUTICAL INSPECTION SOLUTIONS

  • As the governing regulatory document of the European Medicines Agency (EMA), EU GMP Annex 1 discusses a full host of concepts related to manufacture of sterile medicinal products. In contrast to guidance documents issued by the FDA, EU GMP Annex 1 is interpreted as law, requiring strict adherence to the regulatory expectations contained, numerous of which allude to container closure integrity testing. In fact, current proposed and ongoing revisions increase the expectations of scrutiny on package integrity.

  • Used 200 mm Cassel flow thru metal detector, type Shark 2A GF0200. 200 mm diameter aperture, with stainless steel reject system, and digital readout, serial# D180288.03G, built 2018.

  • Inspect critical areas with our leak detection system.

  • The Thermo Scientific™ Versa Flex and Versa Flex GP checkweighers are designed to improve accuracy and reliability, decreasing maintenance and product giveaway. Our global manufacturing and service teams enable a high level of solutions and service support wherever you do business.

  • The HDV-AT6 pinhole inspector provides 100% inspection for glass vials with non-destructive leak testing.