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>
- 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, firstname.lastname@example.org)