Piramal Pharma Solutions Ensures Compliance with Nitrosamine Regulations

Piramal Pharma Solutions has successfully aligned its operations with international guidelines on nitrosamine impurities. Recognized for their potential carcinogenic effects, nitrosamines necessitate stringent regulatory adherence. The company executed a meticulous action plan involving risk assessments, confirmatory testing, and control strategies to ensure safety and compliance.

A cross-functional team of experts drove these efforts, focusing on aligning operations with evolving regulatory expectations. They prioritized thorough risk assessments across drug substances and products, leading to confirmatory testing and control strategies where needed. All Piramal commercial products now meet global regulatory standards, though some customer products await approval.

Piramal invested significantly in testing capabilities and facility enhancements, equipping key sites with the latest technology to mitigate potential drug shortages and impurity challenges. This approach consolidates Piramal's commitment to maintaining high quality and safety standards, positioning them as a reliable partner in the pharmaceutical industry.