BRIEFING

 〈1251〉 Weighing on an Analytical Balance. This proposal is based on the version of the chapter official as of May 1, 2018. 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 Balances 〈41〉 as well as the European Pharmacopoeia chapter “Balances”, it is proposed to make the following changes:

1. In the Introduction, clarify the group of instruments in which balances are included as per Analytical Instrument Qualification 〈1058〉 and its relationship with the analytical target profile described in Analytical Procedure Life Cycle 〈1220〉.

2. Add a new section, Principle, defining weight and units.

3. In Performance Qualification, the risk of the weighing application is explained with regard to the user’s quality management system in order to define the frequency and the type of performance qualification activities.

4. Discuss the frequency of each of the individual tests included, as well as the relationship between calibration and verification.

5. Delete the section Balance Checks and integrate it into Performance Qualification.

6. Simplify the definition of minimum weight and add clarifications about the tare vessel as well as examples to address frequently asked questions.

7. Introduce a safety factor that addresses critical performance changes of the balance during routine usage.

8. Add a Glossary to clarify the use of specific terms.

9. Add Additional Information to ensure alignment of concepts and terminology.

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

 (GCM: Y. Liu)

 Case ID—SUB-970