Piramal Pharma Solutions, a leading global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd, has announced the successful completion of its compliance journey with international standards for nitrosamine impurities in pharmaceuticals.

 

Nitrosamines, unintended carcinogenic byproducts found in certain medications, have prompted evolving global guidelines that demand rigorous industry oversight. In response, Piramal Pharma Solutions implemented a comprehensive, multi-step action plan to align operations with the latest nitrosamine drug substance-related impurity (NDSRI) regulations, putting patient safety at the forefront.

 

The initiative began with the creation of a cross-functional core team, bringing together experts from Regulatory Affairs, Central Quality, R&D, and Manufacturing. This team interpreted emerging regulatory guidance and ensured all operations adhered to international NDSRI standards.

 

A centerpiece of this effort was the development and continual updating of a Position Paper—a centralized guidance document outlining roles and responsibilities, enabling site teams to navigate the new regulatory landscape.

 

Risk assessments were conducted for all relevant drug substances and products, with confirmatory testing, control strategies, and administrative measures applied where needed. Today, all existing Piramal Pharma Limited commercial products meet global regulatory requirements, while new batches and certain customer products await regulatory approval before release.

 

To bolster testing capabilities, Piramal invested in state-of-the-art equipment at its Ahmedabad and Digwal development sites and qualified external laboratories for additional support. These upgrades allow the company to synthesize and qualify impurities in-house, minimize impurity formation, and conduct extra screening studies—mitigating potential drug shortages while addressing industry-wide challenges in impurity standards and synthesis.

 

"At Piramal Pharma Solutions, patient well-being is our top priority. We are proud to have achieved regulatory compliance for nitrosamine impurities, which reflects our unwavering commitment to patient safety and operational excellence, while also solidifying our position as a trusted partner in the industry," said Rashida Najmi, Chief Quality Officer, Piramal Pharma Limited. 

 

"With our proactive approach and enhanced capabilities, we are well-equipped to adapt to evolving global NDSRI standards, ensuring the highest safety and quality standards for our products."

 

As nitrosamine guidelines continue to evolve, Piramal Pharma Solutions pledges to maintain patient safety, regulatory compliance, and operational excellence, supporting partners through transparent communication and continuous improvement.