A REVIEW ARTICLE ON CLEANING VALIDATIONAbstract
Pharmaceutical product and active pharmaceutical ingredients (APIs) can be contaminated by other pharmaceutical products or APIs, by cleaning agents, by microorganisms or by other materials e.g. air borne particle, dust, lubricants, raw materials, intermediates. Mainly cleaning is performed to remove product and non-product contaminating material. Ineffective cleaning can lead to adulterated product, which may be from previous product batches, cleaning agent or other extraneous material introduced into generated by the process. In many cases, the same equipment may be used for processing different products. To avoid contamination source or facility configuration there is a need to ensure that cleaning procedure must strictly follow carefully established and validated method of execution.
D. Narayana Murthy and K. Chitra*
Sri Ramachandra College of Pharmacy, Sri Ramachandra University, Chennai-600 116, Tamil Nadu, India
29 April, 2013
15 June, 2013
14 August, 2013
01 September, 2013