BRIEFING
〈1251〉 Weighing on an Analytical Balance. This proposal is based on the version of the chapter official as of May 1, 2018. On the basis of comments received from stakeholders and to align with the USP Balances 〈41〉 chapter and the Balances chapter in the European Pharmacopoeia, it is proposed to make the following changes to this chapter:
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In the Introduction, clarification is provided on the group of instruments in which balances are included as per Analytical Instrument Qualification 〈1058〉 and its relationship with the analytical target profile (ATP) described in Analytical Procedure Life Cycle 〈1220〉.
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Introduce the new section for Principle, defining weight and units.
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Under Performance Qualification, the risk of the weighing application is explained with regards to the user’s quality management system in order to define the frequency and the type of performance qualification activities.
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Add clarifications in Table 1 to provide additional guidelines for the test examples of the balance properties, based on questions received.
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Include discussion of the frequency of each of the individual tests, as well as the relationship between calibration and performance qualification.
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Delete the section Balance Checks and integrate into the Performance Qualification section.
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Simplify the definition of Minimum Weight, and add clarifications about the tare vessel and examples to address frequently asked questions.
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Introduce a safety factor that addresses critical performance changes of the balance during routine usage.
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Introduce a buoyancy correction when needed as well as other clarifications in the section Operation of the Analytical Balance.
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Add Glossary to clarify the use of specific terms.
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Add Additional Sources of Information to ensure alignment of concepts and terminology.
Additionally, minor editorial changes have been made to update the chapter to current USP style.
(GCMDQ: A. Hernandez-Cardoso)
Correspondence Number—C323141
Current GUID number: GUID-64BFE248-B65C-4D04-9DDE-EBF471C3BF3B