Now a Reality: USP Chapters 41 and 1251 on Balances.
Time is ticking. Get ready for Compliance!
It is now out and official: USP published revised General Chapters 41 "Balances" and 1251 "Weighing on an Analytical Balance" in the Second Supplement to USP 36-NF 31. After a six months transition period the new chapters will be official December 1st 2013. All affected companies need to be compliant with
their balance SOPs updated at that day at the latest.
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. Officially, you 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.
Key Leaming Obiectives:
- Get detailed information on the new requirements described in the USP General Chapter 41 "Balances"
- Learn which tests have to be periodically performed on balances used for quantitative analysis and which acceptance criteria apply from now on
- 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
- Laboratory Managers
- Compliance Managers
- Quality Assurance / Quality Control (QA/QC) Professionals
- Engineering Managers
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 USP, ASTM and EURAMET expert panels.