Piramal Pharma Solutions, a global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd., has achieved regulatory compliance for nitrosamine impurities by implementing a multi-step action plan to ensure regulatory alignment with the latest NDSRI guidelines.

The first step of this proactive approach involved the development of a cross-functional core team comprised of subject matter experts from Regulatory Affairs, Central Quality, R&D, and Manufacturing. These experts offered specialized insights from their unique perspective, interpreted regulatory guidance as it was published, and ensured every operation across our organization remains compliant with international NDSRI guidelines.

This team played a pivotal role in the publication and continual update of the Position Paper, a centralized guidance document aligned with the latest regulatory expectations. By clearly defining roles and responsibilities, the Position Paper enabled site teams to adapt to the challenges and changes associated with the new requirements.

Another critical component of the company’s journey to nitrosamine compliance was prioritizing risk assessments for all relevant drug substances and drug products to analyze their level of safety and regulatory impact. All identified products received confirmatory testing, with control strategies and administrative controls implemented as needed. Currently, all existing Piramal Pharma Limited commercial products comply with global regulatory requirements. Some customer products are still pending approval, and new batches will only be executed following regulatory alignment.

The action plan also involved the development of in-house testing capabilities at key facilities, alongside the qualification of external laboratories to support additional testing needs. This included investments into new equipment and capabilities at the Ahmedabad and Digwal pharmaceutical development sites to expedite testing and compliance processes and mitigate potential drug shortage issues. These enhancements also address industry-wide challenges posed by impurity standards and synthesis difficulties, enabling Piramal to synthesize and qualify impurities in-house, minimize impurity formation, and conduct additional screening studies to confirm product safety.

“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.”