Do USP methods need to be validated by the user?

02.09.2019

Question of the Week

The methods in the USP are validated for the use foreseen in the USP (21 CFR 211.194(a)(2)).The method sought by the USP here is described in chapter <1225> Validation of Compendial Procedures. In this respect, the method in the USP corresponds to that in the European Pharmacopoeia. When working with the USP, however, it is essential for users to perform a verification before carrying out an analytical test.The procedure for this is described in chapter <1226> Verification of Compendial Procedures. This is also required in the FDA validation guideline.

[GMP Compliance Adviser, Chapter 14.K.6]

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