Vol. 1, Issue 4 (2012)

Author(s):
Bodavula Samba Siva Rao, Y. Surendhranath Reddy, M. Jeybaskaran

Abstract:
The cleaning validation is to verify the effectiveness of the cleaning procedure for removal of product residues, degradation products, preservatives, excipients and cleaning agents so that the analytical monitoring may be reduced to a minimum in the routine phase. In addition one need to ensure there is no risk associated with cross contamination of active ingredients. Cleaning validation is intended to address special consideration and issues pertaining to validation cleaning procedures for equipment used in the manufactured of pharmaceutical products, radiopharmaceuticals, and biological drugs. The document is also intended to establish inspection consistency and uniformity with respect to equipment cleaning procedures.