Revision of the General USP Chapter <1010>
Recommendation
13-15 May 2025
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(3) the In-process-revision of the general USP Chapter <1010> - Analytical Data - Interpretation and Treatment - was announced. This revision was suggested due to the proposals the USP received for this capter.
The part on the use of USP reference substances now also describes more detailed the handling of secondary standards which can be traced back to the USP reference standards.
Further, in the entire document the term "method" was replaced by the term "procedure" as far as the description of analytical testing is concerned. This was done in adapting the document to today's USP terminology.
In addition there will be a new Appendix F in which a new statistical test is described for the evaluation of the equivalence of analytical procedures.
Please see the chapter <1010> - Analytical Data - Interpretation and Treatment for further information.
Source: USP - http://www.usp.org
Related GMP News
09.05.2025New ECA Guidance on Sampling and Sample Management
07.05.2025Public Consultation on ICH M13B Guideline on Bioequivalence launched in Switzerland
07.05.2025BioPhorum publishes Guidance for ICH Q2(R2) and Q14 Implementation
23.04.2025OTC Drug Production Ceased after FDA Warning Letter
23.04.2025EMA publishes Draft of ICH M13B Guideline on Bioequivalence
16.04.2025EMA publishes four new product-specific Bioequivalence Guidance