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Piramal Pharma Solutions Achieves Regulatory Compliance

Piramal Pharma Solutions, a leading global Contract Development and Manufacturing Organization (CDMO), has recently confirmed its compliance with the international regulations concerning nitrosamine impurities in pharmaceutical products. This significant development emphasizes the company's dedication to patient safety and operational excellence.

Understanding Nitrosamines

Nitrosamines are unwanted by-products that can form during the manufacturing processes of certain medications, potentially posing cancer risks. In response to evolving global guidelines regarding these impurities, the pharmaceutical sector has been urged to adapt its operations to maintain compliance and ensure safe products for consumers.

Proactive Measures Taken

Recognizing the need for stringent oversight, Piramal Pharma Solutions implemented a comprehensive, multi-step action plan. This initiative not only meets but also exceeds current regulatory expectations surrounding Nitrosamine Drug Substance-Related Impurities (NDSRI).

The proactive approach involved assembling a cross-functional team of regulatory, quality assurance, R&D, and manufacturing experts. This dedicated group focused on interpreting regulations as they evolved, ensuring every operation aligned with international guidelines. Their efforts culminated in the publication of an updated principle statement, which clarified roles and responsibilities within the organization and guided site teams through the latest regulatory challenges.

Comprehensive Risk Assessment

A critical component of the compliance process was the prioritization of risk assessments for all relevant substances and pharmaceutical products. These evaluations were performed to analyze safety levels and regulatory implications. Following this, all identified products underwent verification testing, with additional control strategies implemented wherever necessary. Currently, all existing commercial products from Piramal Pharma Limited meet global regulatory standards, while some client products await approval. Importantly, any new batches will only be produced after confirming adherence to regulations, ensuring maximum safety.

Investment in Testing Capabilities

In addition to risk assessments, Piramal Pharma Solutions invested in enhancing its internal testing capabilities at key facilities. This involved qualifying external laboratories to address supplementary testing demands effectively. Noteworthy improvements were made at the pharmaceutical development sites located in Ahmedabad and Digwal, where new cutting-edge equipment was introduced to streamline testing and compliance processes. These advancements significantly mitigate potential drug shortages while permitting the synthesis and qualification of impurities internally.

Commitment to Patient Safety

Rashida Najmi, Chief Quality Officer of Piramal Pharma Limited, stated, "Patient welfare is our utmost priority. Our successful compliance with nitrosamine regulatory standards reflects our unwavering commitment to safety and operational excellence, consolidating our role as a trusted partner in the industry." With its proactive approach and enhanced capabilities, Piramal is well-prepared to navigate the evolving NDSRI standards.

The Path Ahead

As international guidelines regarding nitrosamines continue to be refined, Piramal Pharma Solutions pledges to uphold patient safety and regulatory compliance. The organization is committed to transparent communication and continuous improvement, ensuring the highest standards of pharmaceutical quality and patient safety for its partners.

About Piramal Pharma Solutions

Piramal Pharma Solutions (PPS) is a global CDMO delivering end-to-end development and manufacturing solutions throughout the drug lifecycle. By operating an integrated network of facilities in North America, Europe, and Asia, we provide a comprehensive range of services, including drug discovery, process development, clinical supply, active pharmaceutical ingredients, and finished dosage forms. Our specialized offerings encompass the development and manufacturing of highly potent active ingredients and antibody-drug conjugates, sterile filling, peptide production, and related services alongside biological product development, including vaccines and gene therapies.

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