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Mettler Toledo Presents In-depth Guidance to Comply with New USP Chapters 41 and 1251 on Balances Used for Quantitative Analysis in the Pharma QC Lab

Tue, 09/04/2012 - 3:09pm
Bio-Medicine.Org

LONDON, September 4, 2012 /PRNewswire/ --

USP published their long awaited new drafts to revise the General Chapters 41 "Balances" and 1251 "Weighing on an Analytical Balance" in the Pharmacopeial Forum PF 38(5).

The new drafts are intended to replace the existing chapters and provide a more user-friendly option for the determination of minimum weight. The documents also propose a risk-based approach to determine type and frequency of routine tests, with the omission of daily balance checks from the drafts in accordance with current FDA thinking.

In response to the updated drafts, Dr Klaus Fritsch, Manager Compliance, Global Business Area Laboratory & Weighing Technologies at METTLER TOLEDO presents a contemporary strategy for best-practice compliance with these new guidelines following Good Weighing Practice™; the global Weighing Standard.

In addition to his role at METTLER TOLEDO, Dr Fritsch frequently consults the industry to help achieve compliance with applicable regulations when using weighing systems. He has been actively involved on committees including the USP Expert Panel to revise the General Chapters 41 and 1251.

In his presentation, Dr Fritsch explains how these revised chapters affect balance quality management and applicable SOPs, especially in the framework of determining minimum weight and executing routine testing.

Session highlights:

  • In depth information on the new requirements of the draft to change USP General Chapter 41 "Balances"
  • Which tests have to be periodically performed on balances used for quantitative analysis and which acceptance criteria apply
  • The two alternatives to assess and calculate the minimum weight of your balances
  • Insight into the risk-based approach to performing balance routine testing as recommended by USP General Chapter 1251 "Weighing on an Analytical Balance"
  • The proper weight selection f
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