Understanding the Upcoming Changes to USP 661.1 and USP 661.2 Requirements

Preparing for the New USP 661.1 and USP 661.2 Requirements



CS Analytical Laboratory, globally recognized as the only FDA-regulated contract laboratory specializing in regulatory solutions for drug and medical device container systems, is excited to announce its upcoming educational webinar. Scheduled for October 29, 2025, this session aims to address the crucial updates regarding USP 661.1 and USP 661.2, with the updated testing requirements set to take effect on December 1, 2025.

Understanding USP 661 Changes


The revisions in the USP 661 chapter present a significant increase in the complexity of test requirements necessary for validating plastic components used in containers and packaging systems. With these changes, it is vital for stakeholders across the pharmaceutical and medical sectors to fully comprehend how these updates affect their product lines. Ronak Patel, the Chemistry Services Laboratory Manager, emphasizes that timely understanding of these modifications is critical to ensuring that products align with FDA regulations.

Aims of the Webinar


The upcoming webinar, running from 11:00 AM to 12:00 PM EST, will feature Ronak Patel and Brandon Zurawlow, the Chief Operations Officer of CS Analytical. During the session, participants will gain invaluable insights into:
  • - The current and pending testing requirements as outlined in USP 661.1 and 661.2.
  • - Effective strategies for implementing these guidelines to optimize compliance with the new standards.
  • - An overview of the differences between the current testing measures and the upcoming requirements, highlighting that prior testing methods will soon become obsolete.

Why Attend?


In the face of the major updates, companies are urged to begin strategizing to address their compliance effectively. With only a few weeks remaining until the new requirements come into play, this webinar serves as a timely opportunity for producers and stakeholders to understand the implications of USP revisions on their operations.

Registration Details


The webinar is free, and registration is easily accessible via this link. Participants can expect to leave with a clearer understanding of how best to navigate the new landscape of testing regulations.

About CS Analytical Laboratory


Dedicated to navigating the intricacies of drug and medical device container testing, CS Analytical Laboratory stands as the leading FDA-regulated institution in the field. The team's expertise encompasses extensive knowledge of the relevant requirements from the USP, EP, and JP standards, ensuring compliance and safety in medical packaging. Offering a comprehensive suite of lab services, including feasibility studies and advanced methods for leak testing, CS Analytical is uniquely equipped to assist firms in fulfilling their regulatory obligations effectively.

For further information and to secure your spot in the webinar, visit CS Analytical's official registration page today and prepare your company to meet the evolving standards of pharmaceutical packaging compliance.

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