FDA Publishes Revised Revised Process-Validation Guidance

[b][COLOR=“blue”]FDA published its long-awaited guidance titled Process Validation: General Principles and Practices this week. The document, which revises and replaces the 1987 guidance titled Guideline on General Principles of Process Validation, explains the components of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients.This guidance emphasizes on Risk.

This has 3 stages[/color][/b]

GMP-REVISION -1.pdf (292.5 KB)