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....
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 | Jun 9, 2025
Cleaning Validation Procedure for Clean-in-Place (CIP) Systems Purpose:To establish and document a systematic approach ensuring that the Clean-in-Place (CIP) system effectively cleans equipment and piping without manual disassembly, preventing cross-contamination and...
by Dr. Yashashwini Reddy | Jun 9, 2025
Sampling in Cleaning Validation in Pharmaceutical Industry Cleaning Validation is a crucial part of pharmaceutical manufacturing to ensure that equipment and production areas are properly cleaned to prevent cross-contamination, ensure product quality, and comply with...
