BRIEFING

 〈41〉 Balances. This proposal is based on the version of the chapter official as of August 1, 2019. The previous proposal, published in PF 49(5) [Sep.–Oct. 2023], has been canceled and is being replaced with this new proposal. On the basis of comments received from stakeholders and to align with Weighing on an Analytical Balance 〈1251〉 as well as the European Pharmacopoeia chapter “Balances for Analytical Purposes”, it is proposed to make the following changes:

1. Introduce the relationship between calibration and performance checks within the life cycle approach to ensure fitness for purpose.

2. Include the concept of a risk-based approach with respect to the frequency of calibration and performance checks.

3. Add a new section on Calibration, clarifying its purpose and including considerations for uncertainty and frequency.

4. Introduce clarifications of compliance with respect to the Repeatability test.

5. Align the term minimum weight with that in 〈1251〉 and in the European Pharmacopoeia, with regard to standard deviation. Include calculation examples.

6. Introduce text that differentiates the minimum weight from the smallest net weight.

7. Clarify criteria to ensure compliance with the required accuracy during performance test checks and calibration, including consideration of the uncertainty of the test weights.

8. Incorporate additional applicable references into the text.

 Additionally, minor editorial changes have been made to update the chapter to current USP style.

 (GCM: Y. Liu)

 Case ID—SUB-968