USP Chapters 41 and 1251 on Balances: New Drafts Published – Learn How to Prepare for Compliance
Presenter: Dr. Klaus Fritsch
Tuesday, September 4, 2012,
8:00 AM - 9:00 AM EST
This Webinar is Available On Demand - Watch Now
Expected already for a long time, USP published new drafts to revise the General Chapters 41 “Balances” and 1251 “Weighing on an Analytical Balance” in the Pharmacopeial Forum PF 38(5) on September 4, 2012. Learn from the GWP® weighing experts of METTLER TOLEDO how these revised chapters will affect your balance quality management and applicable SOPs, especially in the framework of determining minimum weight and executing routine testing. Once the new drafts replace the existing chapters, you officially have an alternative, more user friendly option to determine minimum weight. In respect of routine testing, a risk-based approach is suggested to determine type and frequency of routine tests, and consistent with this approach, a recommendation to carry out a daily balance check is not included anymore in the drafts, also reflecting current FDA thinking.
Attend this webinar to:
- Get detailed information on the new requirements of the draft to change USP General Chapter 41 “Balances”
- Learn which tests have to be periodically performed on balances used for quantitative analysis and which acceptance criteria apply
- Learn about the two alternatives to assess and calculate the minimum weight of your balances
- Get insight into the risk-based approach to performing balance routine testing as recommended by USP General Chapter 1251 “Weighing on an Analytical Balance”
- Learn about the proper weight selection for balance routine testing
Understand that the General Chapters do not talk anymore about daily balance checks
Dr. Klaus Fritsch
Global BA Laboratory & Weighing Technology
Klaus Fritsch, Ph.D. is manager Compliance within the Global Business Area Laboratory & Weighing Technologies at METTLER TOLEDO. He consults the industry to achieve compliance with their applicable regulations when using weighing systems. In this role, Klaus is actively involved in committee work as e.g. EURAMET or ASTM.
GWP® is the only science-based global standard for efficient lifecycle management of weighing systems, developed from the expertise of METTLER TOLEDO.
Lifecycle management according to GWP® consists of evaluation, selection, installation, calibration and routine operation. GWP® is applicable to all kinds of weighing systems of any manufacturer!
Based on the sound scientific principles of the global weighing standard, METTLER TOLEDO offers two unique commercial services: GWP® Verification & GWP® Recommendation.
Service offerings, which guarantee consistent weighing accuracy, audit readiness and feasible cost efficiency, encompassing the entire lifecycle of the weighing equipment.
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Follow Good Weighing Practice™ (GWP®), the Global Weighing Standard, and learn about Accurate Weighing in the Pharmaceutical IndustryPresenter: Dr. Klaus Fritsch
Presenter: Dr. Klaus Fritsch
Possible Consequences for the Pharma Industry if the USP Revision of the General Chapters 41 and 1251 is EnactedContributor: Jeff Holcomb