INSIGHTS ON PHARMACEUTICAL INSPECTION

PHARMACEUTICAL INSPECTION SOLUTIONS

  • Accelerate compliance with CCI methods that deliver reproducible results, ultra-sensitive leak detection, and global regulatory alignment to ensure product integrity while reducing risk and delays.

  • 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.

  • Once material is packaged, secondary packaging is a crucial part of the preparation process. Ropack doesn’t leave anything to chance, with secondary contract packaging services to ensure your products are ready for market when you need them to be.

  • Helium leak detection (HeLD) is routinely used and widely accepted for applications that require the utmost leak sensitivity. This brochure explains how Helium enables the discovery of extremely small microleaks that other leak testing methods cannot detect and what applications it can be used for.

  • Formulation and aseptic filling solutions are crucial at every stage of development. Consider a manufacturing partner who can address every challenge on the path from pre-clinical programs to commercialization.