Compliance & Innovation:
Packaging Systems in an Evolving
Regulatory Landscape

July 10, 2024 | 3 - 4 PM IST

Abstract

In the constant evolving field of pharmaceutical manufacturing, the imperative to embrace new technologies and innovative strategies for enhancing process control and efficiency is more pressing than ever before. Manufacturers are also facing increasing pressure to reduce time to market and total cost of ownership, underscoring the critical importance of prioritizing these areas for a successful launch of a new drug.

This webinar offers a comprehensive overview of recent revisions to EU GMP Annex 1, which became official as of August 25, 2023, and dives into significant changes in the United States Pharmacopeia (USP), including the creation of new chapters <382> and <1382 > to be effective on December 1, 2025. You will also learn how West’s modern elastomer formulation 4031/45 Gray, and high-quality Flip-Off™ seals are developed to meet the expectations of evolving regulatory requirements and help ensure expedited speed to market.

Engage in a conversation with the West India team regarding the primary packaging component, the modern elastomer formulation 4031/45 Gray, and secondary packaging components, the Flip-Off seals, that ensure Container Closure Integrity (CCI), which is a fundamental pillar of the Annex 1 regulations.

Discuss with our experts to learn more about these advancements and their implications for your manufacturing processes.

Key Takeaways:

  • Gain insights about the evolving regulatory requirements for pharmaceutical manufacturing.
  • Explore key considerations for primary and secondary packaging components and system in context with EU GMP Annex 1, USP <382> and <1382>.
  • Learn about West’s modern elastomer formula 4031/45 Gray and high-quality Flip-Off seals.
Speaker

Darshana Chavan Technical Account Specialist, West Pharmaceutical Services

Having more than 12 years of industrial experience in providing technical support to customers in Life-science industry. In her role as the Technical Account Specialist, Darshana provides technical support to pharmaceutical/Biotech companies in India, providing product recommendations, technical trainings and advices to ensure smooth and easy uptake of West’s wide product portfolio as required for customer’s drug product application. Darshana holds a Bachelor of Technology (B.Tech) degree in Biotechnology.