1Department of Pharmaceutical Analysis and Quality Assurance, 2Department of Bio-Technology, Annamacharya College of Pharmacy, Rajampet-516126, Andhra Pradesh, India

Abstract

Cleaning validation is must in order to identify and correction of potential problems previously unsuspected which shows effect on safety, efficacy and quality of subsequent batches of drug product with in the equipment. Manu- factures and authorities set high standards for the effective and reliable cleaning of production equipment in or- der to prevent cross contamination. Regulations, tight deadlines and increasing awareness of cost necessitate effi- cient and residue free cleaning processes. Residue free cleaning is a key factor in the life cycle of any chemical pharmaceutical product from research and development in the laboratory during scale up in the pilot plant and finally at the production site. An effective cleaning process takes all the individual factors in to account and is based on precise knowledge of the product mix and cleaning chemistry which results in greater efficiency and lower costs. The benefits due to cleaning validation are compliance with federal regulations, identification and correction of potential problems, previously unsuspected which could compromise the safety and efficacy of drug products.