A Pocket Guide to Chromatographic Methods Validation

Delphi Analytical Services, Inc. has spent years helping companies in the Pharmaceutical Industry improve their level of compliance with Current Good Manufacturing Practices (CGMPs). This involvement has included large and small companies who have already been subject to regulatory action from FDA as well as companies who are taking preventative measures to avoid regulatory action. As part of this effort, a significant amount of time has been spent reviewing the chromatographic data and chromatographic methods validation reports. This “pocket guide” is designed to provide an overview of chromatographic methods validation. This Guide is intended to be used as a quick reference or “sanity check” to insure that you are addressing the major issues associated with validating chromatographic methods. Soft cover booklet, 64 pages. Not available for download