by Dr. Yashashwini Reddy | Aug 12, 2025
Criteria to Choose the Correct Swab for Cleaning Validation Cleaning validation in pharmaceuticals ensures that residues from previous products, cleaning agents, or contaminants are effectively removed from manufacturing equipment to prevent cross-contamination.Swab...
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
Quality Management System (QMS) 1. Definition A Quality Management System (QMS) is a structured framework of policies, procedures, processes, and resources that ensures pharmaceutical products consistently meet quality, safety, efficacy, and regulatory requirements.It...
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...
