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GMP Process Validation

Documenting Process Validation
A Drugmaker‘s Guide

Here’s a step-by-step manual based on real-world examination experience. You’ll discover how to document process validation in a way that’s sure to satisfy — and impress — regulators.

 
 
PDA Technical Report No. 60 Process Validation
(TR 60)

Interpretation of the requirements of FDA and EMA on the life cycle approach.

 
 
 
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