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In July 2015, the FDA released new comprehensive guidance for validation of analytical methods.

Greg Martin is president of Complectors Consulting (www.complectors.com), based in Pottstown, PA, which provides consulting and training in the area of pharmaceutical analytical chemistry. Mr. Martin has over 25 years of experience in the pharmaceutical industry and was director of pharmaceutical analytical chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the U.S. Pharmacopeia for over 10 years, and currently serves as vice chair of the General Chapters—Physical Analysis Expert Committee and also serves on expert panels on Validation and Verification; Weights and Balances’ Residual Solvents; and Use of Enzymes for Dissolution Testing of Gelatin Capsules.

Adding steps to traditional method validation delivers higher ROI.