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,...
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...
