INSIGHTS ON PHARMACEUTICAL INSPECTION

PHARMACEUTICAL INSPECTION SOLUTIONS

  • The pharmaceutical industry continues to lead industries in terms of quality requirements and the value of data. The shift to more automated processes is less about the cost of human capital, but more about the pursuit of quality. The European Medicines Agency (EMA) updated Annex 1, driving for 100% inspection on fused containers and appropriate quality test measures for applications based on level of risk. The United States Pharmacopeia (USP) revamped Chapter 1207 on container closure integrity (CCI) to be prescriptive of deterministic technologies and encourages a deeper understanding of a container’s CCI requirements. The FDA continues to drive a ‘quality culture’ agenda versus a ‘compliance culture’, and the FDA has been explicitly targeting data integrity as a campaign for assuring quality. Every regulatory and guidance body is driving towards more reliable and accurate test methods.

  • Discover a flexible, high-performance solution that can inspect up to 350 syringes and vials per minute.

  • Upperton provides clinical supplies for Phase 1, Phase 2, and Phase 3, specializing in oral, nasal, and pulmonary dosage forms.

  • Explore the latest in contaminant detection technology with this pharmaceutical metal detector for tablets and capsules. Ensure the highest quality products with its failsafe rejection system and more.

  • ZEROC is the new RTP tester developed to perform a complete integrity test on Rapid Transfer Ports (Alpha part), installed on isolators or RABS, and their containers (Beta part) in a fully automatic way.