by Dr. Yashashwini Reddy | Aug 18, 2025
📋 Procedure for Sampling in Process Validation 1. Preparation Stage Review the approved Process Validation Protocol for sampling details (points, number of samples, method). Ensure that sampling tools and containers are clean, calibrated, and labeled. Train personnel...
by Dr. Yashashwini Reddy | Aug 18, 2025
Purpose of Process Validation in Pharmaceuticals Process validation is a documented evidence-based approach that ensures a manufacturing process, when operated within established parameters, can consistently produce pharmaceutical products meeting predetermined...
by Dr. Yashashwini Reddy | Aug 18, 2025
Three Consecutive Batches for Validation in Pharmaceuticals In the pharmaceutical industry, process validation is a critical requirement to demonstrate that a manufacturing process consistently produces a product meeting predetermined quality attributes. Why three...
by Dr. Yashashwini Reddy | Aug 12, 2025
Concept of Revalidation in Pharmaceuticals 1. Definition Revalidation is the process of repeating validation (process, equipment, cleaning, or analytical method) to ensure that the system or process remains in a state of control throughout its lifecycle.It confirms...
by Dr. Yashashwini Reddy | Aug 12, 2025
How to Write a Validation Protocol A Validation Protocol is a formal, approved document describing how validation will be performed, including the methodology, acceptance criteria, responsibilities, and documentation requirements.It applies to Process Validation,...
