Revision of USP <1099> Limit on Number of Large Deviations When Assessing Content Uniformity in Large Samples
Recommendation
Wednesday, 1 October 2025 13.00 - 17.00 h
Register now for ECA's GMP Newsletter
In the Pharmacopeial Forum, PF 47(4), a proposal of USP Chapter <1099> Limit on Number of Large Deviations When Assessing Content Uniformity in Large Samples has been published for comments.
The proposal is based on the version of the monograph official as of March 1, 2019, but the chapter was completely revised.
According to the USP, the new chapter "is presented with a general approach that provides a process for evaluating the number of observed results that fall outside defined limits. The approach can also be used for tests that are inherently pass/fail in nature. It should be noted that the procedure described in this chapter is not intended as a batch release test for content uniformity nor as a replacement of or alternative to Uniformity of Dosage Units <905> for compendial purposes."Comments on the chapter can be submitted from now on. The comment deadline is September 30, 2021.
The draft can be viewed here. (Please note: a one-time registration is required to access the Pharmacopeial Forum.)
Related GMP News
14.07.2025Inadequate Sampling and Component Testing Highlighted in FDA Warning Letter
14.07.2025EMA publishes new Product-Specific Bioequivalence Guidance
14.07.2025Revision of USP Chapter <1039> Chemometrics Published for Comments
14.07.2025Proposal for new USP Chapter <318> NMR Monomer Ratio Determination for Lactide-Glycolide Polymers
14.07.2025New USP Chapter <1221> on Ongoing Procedure Performance Verification (OPPV) Published for Comment
02.07.2025FDA Warning Letter: Missing Testing, No Stability Data, and Inadequate Raw Material Controls