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General Chapter Prospectus: <1331> Calibration and Verification of Volumetric Apparatus

Posting Date: 26-Feb-2021
Expert Committee: General Chapters—Measurement and Data Quality

Proposed New Title: <1331> Calibration and Verification of Volumetric Apparatus

Suggested audience: Suppliers and manufactures of drug substance, biologics, drug products, excipients, parenteral products, contract manufacturing organizations, dietary supplement manufacturers, drug testing organizations, drug products related regulatory agencies, and QA/QC specialists

Estimated proposal PF: Pharmacopeial Forum 47(6) [Nov.-Dec. 2021]

Background and objective: USP intends to develop a new informational general chapter to support General Chapter <31> Volumetric Apparatus that will contain recommendations for calibration and verification process.  

Description of scope and application: This informational chapter will describe the process for calibration and verification of volumetric apparatus described in chapter <31>, in order to demonstrate that it meets the laboratory’s requirements and complies with the relevant specifications for the duration of use. 

Preliminary outline: The following represents the sections for the proposed General Chapter <1331>

  • INTRODUCTION
  • GENERAL CONSIDERATIONS: Identification of general/critical aspects that should be considered during calibration and/or verification process (e.g., identification of volumetric apparatus-types and classes of glassware; volumetric apparatus care – segregations, storage and visual inspections). 
  • CALIBRATION PROCESS: This section provides recommended specifications, procedures (types of calibrations) and frequency that should be considered by the laboratory.
  • VERIFICATION PROCESS: This section provides recommended specifications, procedures and frequency that should be considered by the laboratory.
  • CLEANING PROCESS: The section provides the recommended specifications (e.g., validation of cleaning procedure) and procedures that should be considered by the laboratory.
  • CALCULATIONS: This section provides recommended calculations to support calibration and/or verification process.
  • REFERENCED DOCUMENTS: This section provides reference documents to support previous sections. 

Anticipated activities: USP is requesting early input from stakeholders on this newly proposed General Chapter <1331> which is planned to be published for comment in Pharmacopeial Forum.

Contact: Antonio Hernandez-Cardoso, Senior Scientific Liaison (301-816-8308, ahc@usp.org


CN-21-041-00