Understanding of USP<1058> updates and insights in regulations

by | Impurity Analysis, Pharmaceutical

Learn about how USP <1058> aligns with GAMP® 5, the core elements of the <1058> instrument life-cycle framework, and areas of <1058> the USP are exploring improvements in by attending this upcoming webinar.


Date: 25 January, 2023

Start Times: 
Broadcast #1: 25 January - starting at 9am GMT (London) / 10am CET (Paris) / 2.30pm IST (Mumbai) / 5pm SGT (Singapore)
Broadcast #2: 25 January - starting at 11am PST (Los Angeles) / 1pm CST (Chicago) / 2pm EST (New York)

Duration: Approximately 1 hour

The United States Pharmacopeia (USP) is the only major pharmacopeia with a general chapter dedicated to analytical instrument qualification (USP <1058>). This makes <1058> a globally significant regulatory reference. However, despite the significant changes with the 2017 edition of <1058>, 68% of laboratories have not updated their qualification procedures. Additionally, the USP has already started the process to initiate updates to <1058>, when many laboratories may not fully comply with the current edition!

This raises many questions about the role of the current <1058> general chapter and how it aligns with the recently issued 2nd Edition of GAMP® 5.

By viewing this presentation you will learn about:

  • How USP <1058> aligns with GAMP® 5
  • Core elements of the <1058> instrument life-cycle framework
  • Areas of <1058> the USP are exploring improvements in

The Presenter

PaulSmith_200Paul Smith
Global Laboratory Compliance Marketing Specialist (USP <1058>),
Agilent Technologies, Inc.

Paul has a passion for laboratory compliance and started his career as an Infrared Spectroscopist, performing his first FT-IR software validation in 1992, 30 years ago. In his current Agilent role, Paul is an active member of GAMP, a member of the UK GAMP Community of Practice (CoP) steering committee and has contributed to GAMP® Good Practice Guides. He helps laboratories understand their laboratory instrument qualification requirements and writes publications and white papers about this.



Published  Jan 11, 2023

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