INSIGHTS ON PHARMACEUTICAL INSPECTION

PHARMACEUTICAL INSPECTION SOLUTIONS

  • Ropack Pharma Solutions utilizes state-of-the-art technology to ensure the efficacy, potency and robust shelf life of the products we manufacture and package.

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

  • Referenced in the new USP <1207> Chapter Guidance as a deterministic test method for container closure integrity testing.

  • 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.

  • 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.