USP Chapters 41 and 1251 on Balances: New Drafts Published – Learn How to Prepare for Compliance
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
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