Analytical Procedures and Methods Validation for Drugs and Biologics

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FDA has published “Analytical Procedures and Methods Validation for Drugs and Biologics” (July 2015). This is a very significant document as it is replacing the 2000 guidance and it now reflects ICH Q2(R1) guidances.

The recommendations apply 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. The principles in this guidance also apply to drug substances and drug products covered in Type II drug master files (DMFs).

The guidance also suggests that a risk-based approach concerning revalidation of existing test methods should be employed when the manufacturing process changes during the product’s life cycle. The guidance recommends the outline of what should be included when preparing an analytical method procedure. The guidance clearly states that USP methods should be verified through a written verification protocol.

Download the guidance here.