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.
What you need to know:
Duration: Approximately 1 hour
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.