Balances - Correction of the Requirements in the U.S. Pharmacopoeia (USP)
Recommendation
23-25 May 2023
Vienna, Austria
Practical Approaches for USP General Chapter <1058> Compliance in the QC Laboratory
Register now for ECA's GMP Newsletter
In the Pharmacopoeial Forum 40(1) a short-term revision of the General Chapter <41> with regard to balances was announced as "interim revision announcement".
Questions that arrived at the USP indicate that there is a potential problem with the requirement of repeatability in the verification of scales. If you follow the procedure as described, the use of a large test weight can cause false positive results.
To resolve this problem, the expert group of the USP proposes a modified test in which the "smallest desired net weight" is now incorporated in the formula for the repeatability as well.
If there are no contrary comments, this "interim revision announcement" will become effective as of 1 July 2014.
All other information are available on the USP website of the Pharmacopeial Forum (PF).
Source: USP - http://www.USP.org
Related GMP News
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
- Good Distribution Practice
- Sterile Manufacturing
- Computer Validation
- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- Impurities
- OOS / OOE / OOT
- Material Testing
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Microbiological Testing
- Technology
- General Manufacturing Topics
- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others