Published on IVT Network (http://www.ivtnetwork.com ) FDA Signals a New Approach for Analytical Method Validation By Tim Sandle, Ph.D. Aug 17, 2015 11:00 pm PDT ABSTRACT The U.S. Food and Drug Administration (FDA) has published its long-awaited Guidance for Industry document "Analytical Procedures and Methods Validation for Drugs and Biologics." The purpose of the guidance is support of new drug applications and what types of data are needed for new drug applications. Sections in the document listed. Key changes are described. These include: Scope, length, risk assessment, new sections, immunoassay and bioassay; essential information, reference standards, re-validation, and method transfer. The new guidance offers a clear signal to the industry as the FDA expectations for analytical methods and data presentation in support of new drug applications. INTRODUCTION The U.S. Food and Drug Administration (FDA) has published its long-awaited Guidance for Industry document "Analytical Procedures and Methods Validation for Drugs and Biologics" (1). The revised guidance was published in July 2015 and it supersedes the draft of the same name that published on February 19, 2014 (2). The document is important for laboratory staff and pharmaceutical organizations to digest. It outlines the Agency's recommendations for qualifying and running analytical methods. Moreover, there are several changes since the original version of the document was released fifteen years ago. The purpose of the guidance is support of new drug applications and what types of data are needed for new drug applications. The document is concerned with the types of analytical methods used to assess the identity, strength, quality, purity, and potency of drug substances and drug products. This includes methods that support new drug applications and biologics license applications. Tests should be conducted and described in sufficient detail so that they can be reproduced in another laboratory by a different qualified analyst. The document also extends beyond the operation of the methods in considering how to select, interpret, and present data collected from analytical methods. The new document is the FDA's third set of guidances in this subject area. The first appeared in 1987; the second in 2000; the third, although welcome, has taken far too long, especially given the pace in pharmaceutical laboratory technology. One beneficial outcome from the delay is that the document is now better aligned with guidance on the same topic from the International Conference on Harmonisation (ICH). CONTENT The guidance is an important one for industry. Key sections in the document, and where recommendations are made, are the following: Analytical methods development Content of analytical procedures Reference standards and materials Analytical method validation Statistical analysis and models