%0 Journal Article
%T Current Perspectives on Cleaning Validation in Pharmaceutical Industry: A Scientific and Risk Based Approach
%A Harshal A. Pawar
%A Nandini D.Banerjee
%A Sandip Pawar
%A Prashant Pawar
%J International Journal of Pharmaceutical and Phytopharmacological Research
%D 2011
%I International Journal of Pharmaceutical and Phytopharmacological Research
%X In the manufacturing of the pharmaceutical products it is a must to reproduce consistently the desired quality of product. The current Good Manufacturing Practice (cGMP) regulations recognize that cleaningis a critical issue to ensure product quality. The control of cross contamination plays a very important role in maintaining the quality of the product. The manufacturing of API and pharmaceutical products involves series of processing steps and use of various equipments. In many cases, the same equipment may be usedfor processing different products. Residual materials from the previous batch of the same product or fromdifferent product may be carried to the next batch of the product, which in-turn may alter the quality of the subjected product. An effective cleaning shall be in place to provide documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product includingintermediates and impurities, cleaning agents and extraneous material into subsequent product to a levelwhich is below predetermined level. The documented evidence of the consistent performance of thecleaning process is given by the validation process. It ensures safety, efficacy, and quality of the subsequentbatches of drug product. In this article the various aspects of the cleaning validation such as different types of contaminants, sampling procedures, analytical techniques and regulatory requirements are discussed indetail.
%K Contaminants
%K Cleaning validation
%K TOC
%K HPLC
%K FDA
%U http://www.eijppr.com/3%20Current%20Perspectives%20on%20Cleaning%20Validation%20in%20Pharmaceutical%20Industry%20A%20Scientific%20and%20Risk%20Based%20Approach.pdf