07 August 2015

FDA Guidance on Analytical Procedures and Methods Validation for Drugs and Biologics

The U.S. Food and Drug Administration released a final guidance on Analytical Procedures and Methods Validation for Drugs and Biologics.  The guidance document provides recommendations for submitting analytical procedures and methods validation data to support the documentation of the identify, strength, quality, purity and potency of drug substances and drug products.  The scope of the guidance document applies to drug substances and drug products covered in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and supplements to these applications.

Read the Guidance document here


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