Revision of the General USP Chapter <1010>
Recommendation
10/11 September 2025
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
06.08.2025EMA publishes Overview of Comments received on ICH M13B Guideline on Bioequivalence
06.08.2025FDA Warning Letter: Company Voluntarily Ceases Drug Production
23.07.2025New HPTLC Chapter Proposed for The International Pharmacopoeia
22.07.2025AQCG Organises One-Day Track at PharmaLab 2025
22.07.2025ICH publishes Training Materials on Q2(R2) and Q14