Tagged "process-validation"

Concurrent vs Prospective Validation — When Each Approach Applies

The difference between concurrent and prospective validation, and the circumstances that justify each.

Process Validation — Stage 2 (PPQ) Protocol Design

What a Process Performance Qualification protocol needs to define before commercial batches begin.

Process Validation — Three-Stage Lifecycle Approach (FDA 2011 Guidance)

How process design, process qualification, and continued verification fit together under the modern FDA approach.