Piramal Pharma Solutions: Meeting Global Regulatory Standards for Nitrosamine Contaminants

Piramal Pharma Solutions: Compliance with Nitrosamine Standards

Piramal Pharma Solutions, a prominent Contract Development and Manufacturing Organization (CDMO), is making headlines as it successfully adheres to global regulatory requirements regarding nitrosamine impurities in pharmaceutical products. With ongoing changes in international standards, the company has adopted a comprehensive action plan to ensure patient safety and product compliance.

Nitrosamines are inadvertent carcinogenic byproducts that can emerge in certain medications, heightening the necessity for stringent regulations. These standards have been advancing rapidly, compelling pharmaceutical companies to refine their processes to maintain compliance. In response, Piramal Pharma Solutions has established a robust, multi-layered action plan aimed primarily at satisfying the latest nitrosamine drug substance-related impurities (NDSRI) guidelines and ensuring patient safety.

A Structured Approach to Compliance

The company's proactive measures included assembling a cross-functional core team that draws from expertise in Regulatory Affairs, Central Quality, Front-End Operations, and Production. This team collaborated to interpret official regulatory guidelines, ensuring that operations across Piramal align with international NDSRI standards. Their efforts have led to a published position paper that acts as a centralized reference for the latest regulatory requirements by clearly defining roles and responsibilities across teams.

A significant aspect of Piramal's compliance strategy was prioritizing risk assessments for relevant drug substances and formulations. This evaluation determines safety levels and regulatory implications, with identified products undergoing confirmatory testing. When necessary, control systems and administrative procedures were instituted to satisfy requirements. Currently, all commercial products from Piramal Pharma Limited comply with international regulations, and some customer items are pending approval, with new batches awaiting regulatory alignment.

Investments in Facilities and Capabilities

Piramal's action plan has also involved strengthening internal testing capacities at key facilities and qualifying external laboratories to cater to increased testing needs. This endeavor includes significant investments in cutting-edge equipment and capabilities at pharmaceutical development sites in Ahmedabad and Digwal. These advancements not only expedite testing and compliance processes but also address industry-wide challenges associated with contamination standards and synthesis difficulties.

The enhancements empower Piramal to synthesize and qualify impurities internally, minimizing contaminant formation and facilitating additional screening studies for product safety verification. This commitment ensures that the company can effectively navigate a complex regulatory landscape while providing safe and compliant pharmaceutical products.

Commitment to Patient Safety

According to Rashida Najmi, Chief Quality Officer at Piramal Pharma Limited, patient well-being remains the paramount priority. The successful adherence to nitrosamine regulatory requirements reflects the company’s commitment to patient safety and operational excellence while solidifying its reputation as a trusted industry partner. "With our proactive approach and enhanced capabilities, we are well-prepared to adapt to evolving global NDSRI standards and ensure the highest safety and quality standards for our products,” Najmi affirmed.

Piramal Pharma Solutions is cognizant of the ongoing developments in nitrosamine guidelines and maintains a steadfast commitment to regulatory compliance and operational excellence. The company pledges to support its partners in facing the complexities of nitrosamine control while prioritizing transparent communication and continuous improvement to uphold the highest standards of pharmaceutical quality and patient safety.

Overview of Piramal Pharma Solutions

Piramal Pharma Solutions is a leading CDMO that offers end-to-end development and manufacturing solutions for the entire lifecycle of drugs. Serving clients through a globally integrated network across North America, Europe, and Asia, Piramal provides a comprehensive range of services including drug research solutions, process and pharmaceutical development services, clinical trial supplies, commercial API delivery, and finished dosage forms. Specialized offerings such as the development and manufacture of highly potent APIs, antibody-drug conjugates, sterile filling, and effective solid oral dosage forms further bolster its portfolio. Additionally, Piramal extends its services to biologics like vaccines and gene therapies through its affiliate, YapanBio Private Limited.

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