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
Cleaning Validation of Pharmaceutical Equipment Cleaning Validation is a documented process that provides a high degree of assurance that equipment used in the manufacturing of pharmaceutical products is consistently cleaned to predetermined and acceptable limits. It...
by Dr. Yashashwini Reddy | Aug 18, 2025
FDA Warning Letters for Cleaning Validation The FDA frequently issues Warning Letters to pharmaceutical manufacturers for deficiencies in cleaning validation programs, as inadequate cleaning can lead to cross-contamination, adulteration, and patient safety risks....
