by Dr. Yashashwini Reddy | Aug 18, 2025
Cleaning Validation Procedure for Clean-in-Place (CIP) Systems 1. Objective To establish a validated cleaning procedure for Clean-in-Place (CIP) systems ensuring removal of product residues, cleaning agents, and microbial contaminants to acceptable levels. 2. Scope...
by Dr. Yashashwini Reddy | Aug 18, 2025
Sampling in Cleaning Validation in Pharmaceutical Industry Introduction Cleaning validation is a critical part of pharmaceutical manufacturing, ensuring that residues of products, cleaning agents, and microbial contaminants are effectively removed to avoid...
by Dr. Yashashwini Reddy | Aug 18, 2025
Recovery Factor Determination in Cleaning Validation Definition:Recovery Factor (RF) is the percentage of analyte recovered from a surface during cleaning validation studies. It helps to account for possible losses during swabbing/rinsing and analytical testing,...
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...
