A REVIEW ON CLEANING VALIDATION- CLEANING METHOD DEVELOPMENT


Saurav B. Sahare, Dr.Swati Ravat, Dr.Sunil Jaybhaye, Mr.Yogiraj Mule, Saurabh Bondre
Institute of Pharmacy, Badnapur, Dist. Jalna, Maharashtra
Abstract
Cleaning validation is a critical process in the pharmaceutical and biotechnology industries, ensuring that equipment and facilities are adequately cleaned to prevent cross-contamination and ensure product quality. This abstract discusses the importance of cleaning validation protocols, the methodologies employed, and the regulatory guidelines governing the process. It highlights key steps, including risk assessment, selection of appropriate cleaning agents, and the validation of cleaning procedures through analytical methods.Additionally, the abstract addresses the challenges faced during validation, such as variability in residue limits and the need continuous monitoring. Emphasizing a risk-based approach, this paper outlines best practices to achieve compliance with industry standards while safeguarding patient safety and product integrity. The findings underscore the necessity of robust cleaning validation as an integral part of quality assurance in manufacturing environments
Keywords:
Journal Name :
EPRA International Journal of Multidisciplinary Research (IJMR)

VIEW PDF
Published on : 2024-11-28

Vol : 10
Issue : 11
Month : November
Year : 2024
Copyright © 2024 EPRA JOURNALS. All rights reserved
Developed by Peace Soft