#India #Mumbai #Piramal Pharma #Regulatory Compliance #Nitrosamine Impurities

Piramal Pharma Solutions Achieves Compliance for Nitrosamine Impurities

Piramal Pharma Solutions, a key player in the global Contract Development and Manufacturing Organization (CDMO) sector, recently announced a significant milestone in ensuring compliance with evolving international standards regarding nitrosamine impurities. The company has implemented a comprehensive action plan designed to safeguard both regulatory adherence and patient safety.

Understanding Nitrosamines

Nitrosamines are unintentional carcinogenic byproducts that can occur in certain pharmaceuticals. Over recent years, international guidelines surrounding these impurities have rapidly changed, necessitating a reevaluation of practices within the pharmaceutical industry. As part of this, Piramal Pharma Solutions has proactively aligned its operations with the latest regulations to mitigate any potential risks associated with nitrosamines.

A Multi-Faceted Approach to Compliance

The company's journey toward regulatory compliance began with the establishment of a specialized cross-functional team. This team consists of experts from various departments, including Regulatory Affairs, Central Quality, Research & Development, and Manufacturing. With their expert insights, they interpreted regulatory updates as they were released and ensured that all of Piramal's operations complied with the latest guidelines.

A pivotal aspect of this proactive strategy was the development of a Position Paper, a centralized guidance document that outlines regulatory expectations and defines roles and responsibilities essential for compliance. This framework facilitated clear communication across the organization, allowing individual site teams to adapt to the evolving regulatory landscape successfully.

Prioritizing risk assessments was crucial in this compliance initiative. The company conducted thorough analyses of all pertinent drug substances and products to evaluate their safety and regulatory implications. Confirmatory testing was carried out for all identified products, and necessary control strategies were established. As a result, Piramal Pharma's commercial products now meet global regulatory standards, with pending approvals being addressed methodically.

Enhancements in Testing Capabilities

To further bolster its compliance initiatives, Piramal invested in creating in-house testing capabilities at key facilities and qualified external laboratories to support additional testing needs. Significant investments in new, cutting-edge equipment and enhancements were made at the Ahmedabad and Digwal pharmaceutical development sites. Such advancements will expedite testing and compliance processes and alleviate potential issues related to drug shortages.

Additionally, these measures will enable the company to synthesize and qualify impurities internally, minimizing their formation while conducting thorough screening studies to ensure product safety.

Commitment to Patient Safety

"At Piramal Pharma Solutions, patient well-being remains our utmost priority. Achieving compliance with nitrosamine impurity regulations exemplifies our enduring commitment to patient safety and operational excellence. This success also reinforces our reputation as a trusted industry partner," stated Rashida Najmi, Chief Quality Officer of Piramal Pharma Limited.

With a proactive approach and improved capabilities, Piramal is well-prepared to adjust to the constantly evolving global standards concerning nitrosamines, assuring the highest levels of safety and quality in its pharmaceutical offerings.

Looking Ahead

As guidelines on nitrosamines continue to evolve, Piramal Pharma Solutions emphasizes its dedication to maintaining patient safety and regulatory compliance. The company's commitment extends to supporting partners in navigating the complexities of nitrosamine control, fostering transparent communications, and continuously enhancing processes to uphold the highest pharmaceutical quality standards.

About Piramal Pharma Solutions

Piramal Pharma Solutions is a Contract Development and Manufacturing Organization that provides comprehensive development and manufacturing solutions across the drug life cycle. With a network of facilities across North America, Europe, and Asia, Piramal services the pharmaceutical industry with end-to-end solutions ranging from drug discovery to commercial supply of APIs and finished dosage forms.

Conclusion

The successful implementation of compliance measures by Piramal Pharma Solutions not only reflects a commitment to customer safety and regulatory adherence but also sets a benchmark for the pharmaceutical industry as a whole. As the landscape of drug manufacturing continues to evolve, Piramal stands at the forefront, ensuring its practices meet the highest standards of quality and safety.