INSIGHTS ON REGULATORY COMPLIANCE

REGULATORY COMPLIANCE SOLUTIONS

  • 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.

  • Sterility is key for high-risk applications such as injectables, parenteral formulations, ophthalmic and peritoneal dialysis solutions, and many more.

  • Review the potential of Corning Valor® Glass to optimize the fill/finish process and reduce total cost of quality as well as overall manufacturing cost.

  • Examine how sterilizing-grade filters with high flux and broad compatibility support efficient bioprocessing across mAbs, vaccines, and viral vectors.

  • Approach for US FDA 21 CFR Part 11 electronic records and electronic signatures: IDBS PIMS has been designed, developed and tested to enable compliance to 21 CFR Part 11 to accommodate the regulatory needs of its users.