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.

  • Developments in non-destructive, deterministic testing technologies that can achieve optimum assurance in container closure for biologics.

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

  • The Food and Drug Administration (FDA), United States Pharmacopeia (USP) and EMA Annex 1 issue strict guidelines for testing the integrity of IV bags and containers closed by fusion. IV bag manufacturers are one among many sterile product manufacturers that must meet these test requirements for container closure integrity.

  • Our Switch 75 comes standard with an integrated de-/renester system, but can also be integrated into your production line via turn table or directly inline. Two inspection carousels allow the inspection of vials and syringes on one machine.