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Drug manufacturers face increasing pressure to minimize patient risk. They are looking for a robust, holistic control plan and a continuous improvement mindset to achieve the highest quality and safety standards. Concerns about particulates are growing, and the global regulations are becoming more stringent. For example, from 2018 through 2022, 34% of FDA recalls for approved injectable products were attributed to issues with foreign particulates or a lack of sterility attributable to the container closure being suboptimal. 1,2

The presence of visible or sub-visible particles is a common reason for drug product recalls. Potential particulate contamination can arise from both direct and indirect contact materials, such as fill-finish equipment, packaging components (e.g. closures and containers), and upstream materials and processes.

The webinar will focus on understanding regulatory guidance and requirements for particulates in injectable packaging systems and will provide a brief overview on sources and test methods for evaluation. It will also introduce how risk mitigation factors and West product offerings help to avoid particulate risk in injectables, specifically designed for vial containment systems.

Join us to learn more and engage with the West India team about the sources of particulates, control strategies, and regulatory guidance on particles for primary/secondary packaging components used in vial containment systems.

References

1.U.S. Food and Drug Administration. (2023, February 21). Drug Recalls. Retrieved September 1, 2022, from https://www.fda.gov/drugs/drug-safety-and-availability/drug-recall
2.U.S. Food and Drug Administration. (2023, January 24). Recalls (Biologics). Retrieved October 17, 2022, from https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/recalls-biologics

Vikrant Chadawar

Sr.Technical Account Specialist, India

Vikrant is a seasoned professional with over 17 years of experience in the pharmaceutical industry. As a Senior Technical Account Specialist at West Pharmaceutical Services, he plays a crucial role in supporting the Commercial Team through technical services/knowledge, marketing initiatives, and fostering external relationships within the pharmaceutical packaging sector. In his role, Vikrant is primarily responsible for providing comprehensive technical assistance related to West's products, processes, and service portfolio. He adeptly supports multiple accounts and business teams, ensuring that customer needs are met with precision and expertise. Vikrant holds a master’s degree in pharmacy from Mumbai University and has a strong background as a formulation scientist.