- Piramal Pharma Solutions has completed its compliance programme for global nitrosamine impurity requirements across all existing commercial products.
- The company established cross-functional teams, developed internal testing capabilities, and updated control strategies to align with evolving international NDSRI guidelines.
Piramal Pharma Solutions has announced the completion of its organisation-wide effort to comply with global requirements for nitrosamine impurities in pharmaceuticals. Nitrosamines are unintended carcinogenic byproducts, and regulatory expectations for nitrosamine drug substance-related impurities have expanded in recent years. The company stated that its multi-step action plan was designed both to meet regulatory expectations and to support patient safety.
A cross-functional core team was established with representation from Regulatory Affairs, Central Quality, R&D and Manufacturing. This group monitored evolving regulatory guidance, updated internal processes and published a central Position Paper to align site operations with international NDSRI standards. The document clarified roles and responsibilities and supported teams adapting to new requirements.
The company prioritised risk assessments for relevant drug substances and drug products, followed by confirmatory testing. Control strategies and administrative measures were implemented where required. Piramal confirmed that all of its existing commercial products comply with global regulatory requirements, while some customer products remain under review, with future batches contingent on regulatory alignment.
In-house testing capabilities were expanded at key facilities, and external laboratories were qualified to support additional needs. The action plan included investments in new equipment at the Ahmedabad and Digwal pharmaceutical development sites to accelerate testing, reduce drug shortage risks and address challenges related to impurity standards and synthesis. The company noted that these enhancements enable it to synthesise and qualify impurities in-house and minimise impurity formation.
“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.”
Rashida Najmi, Chief Quality Officer at Piramal Pharma Limited
Piramal stated that it will continue to support partners navigating international nitrosamine guidance, with a focus on transparency, continuous improvement and maintaining high quality standards across its contract manufacturing network.
