Validation in Pharmaceutical Industry : Cleaning Validation - A Brief
Abstract
The purpose of cleaning validation is to establish the documented evidence with high degree of assurance that the cleaning process followed as per standard operating procedure for cleaning the equipment used for the processing, consistently and concurrently yields the results not exceeding predetermined acceptance limit. The main objective of this particular study is to develop some understanding for the process of validation and its type along with importance of cleaning validation in pharmaceutical industry to prevent cross contamination. This topic includes Types of validation, cleaning validation, Levels of cleaning Validation, Cleaning mechanisms, cleaning agents used and process followed by pharmaceutical industry to achieve cleaning validation. The various methods used for cleaning validation are clearly discussed in this review.
References
2. Anjaneyulu, Marayya; A text book of Quality assurance and quality management in pharmaceutical industry; Good manufacturing practice page no: 144-145.
3. Phviral: Process validation. An essential process in pharmaceutical industry Pharmainfo.net, 2010-01-10.
4. Monohar A.Potdar; A text book of current good manufacturing practice; pharmaceutical validation page no: 413-462.
5. Destin A.Leblanc; A text book of validated cleaning technologies for pharmaceutical manufacturing.
6. Active pharmaceutical ingredient committee: cleaning validation in active pharmaceutical ingredients manufacturing plant, aic.cefic.org/pub/4cleaningvalidation9909.pdf, September 1991.
7. Health sciences authority: regulatory guidance, cleaning validation, has.gov/publish/…/guide-moa-008-006-web.pdf, December 2008.
8. Cleaning Validation for Biopharmaceutical Manufacturing at Genentech, Inc. Part 2, pharmaceuticalvalidation.blogspot.in

