Revised USP Chapter <1225> "Validation of Compendial Methods" approved

The U.S. Pharmacopeial Convention (USP) approved the revised general chapter <1225> Validation of compendial Methods. The proposed revision has been published in Pharmacopeial Forum (PF) 42(2) and was open for comments until May 31, 2016.

As reported in a previous news regarding the draft general chapter <1225> in PF 42(2) this chapter is being revised to incorporate a section on Lifecycle Management of Analytical Procedures. The revision is an attempt to better align the validation concept with the U.S. Food and Drug Administration (FDA) guidance Analytical Procedures and Methods Validation for Drugs and Biologics issued in 2015. The FDA guidance contains a section LIFE CYCLE MANAGEMENT OF ANALYTICAL PROCEDURES providing the following steps to be considered when a change is made to an analytical procedure:

  • Revalidation,
  • Analytical Method Comparability Studies (when substitution of an FDA-approved analytical procedure with an alternative analytical procedure is proposed or when an analytical method is transferred from one laboratory to the other),
  • Reporting Postmarketing Changes to an Approved NDA, ANDA, or BLA.

The revised chapter <1225> has been released in the first supplement to USP 40-NF 35 on February 1, 2017 and will become official on August 1, 2017. However, the previously proposed section on Lifecycle Management of Analytical Procedures has not been added. The revised chapter does only include a reference to general chapter The Dissolution Procedure: Development and Validation <1092> in section Data Elements Required for Validation. Additionally, minor editorial changes have been made to update the chapter to current USP style.

The general chapter <1225> is one of a set of chapters to be amended in the context with USP´s approach for a comprehensive analytical lifecycle concept together with the elaboration of the new general chapter <1220> The Analytical Procedure Lifecycle

A further step towards this approach is the draft of a new USP General Chapter <1210> Statistical Tools for Procedure Validation which has been published in Pharmacopeial Forum (PF) 42(5) in September 2016. Depending on the current development of <1220> and <1210>, chapter <1225> may be revised again to align with these chapters.

For more information please visit the USP website.

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