by Dr. Yashashwini Reddy | Aug 12, 2025
Sampling and Testing in Exhibit and Process Validation Batches 1. Introduction Exhibit Batches: Produced at commercial scale (or pilot scale in some cases) before product launch, used to demonstrate manufacturing feasibility and generate stability, quality, and...
by Dr. Yashashwini Reddy | Aug 12, 2025
Aspect Process Validation Product Validation Definition Documented evidence that a manufacturing process, operated within established parameters, can consistently produce a product meeting its predetermined quality attributes. Documented evidence that a specific...
by Dr. Yashashwini Reddy | Jun 9, 2025
Purpose of Process Validation in Pharmaceuticals Process validation is a critical activity in pharmaceutical manufacturing that ensures a process consistently produces a product meeting its predetermined quality attributes. The purpose of process validation is to...
by Dr. Yashashwini Reddy | Jun 9, 2025
Three Consecutive Batches for Validation in Pharmaceuticals Definition: In pharmaceutical manufacturing, validation is the documented evidence that a process consistently produces a product meeting its predetermined quality specifications. One of the critical...
by Dr. Yashashwini Reddy | May 19, 2025
What Is Revalidation? Revalidation involves repeating the original validation effort or a portion of it to confirm that a process, system, or equipment remains in a state of control. This process is essential when changes occur that could impact product quality or...
