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Abstract

DESIGNING OF CLEANING VALIDATION PROGRAM FOR ACTIVE PHARMACEUTICAL INGREDIENTS

*S.Venugopal

ABSTRACT

Cleaning validation is an important activity in the manufacturing of active pharmaceutical ingredients and its intermediates. Cleaning validation gives the assurance that the previous products residues are completely removed from the equipment, facility, system and area prior to the next product manufacturing. Regulatory agencies like USFDA, MHRA, EDQM etc., are more interested in reviewing the organization policies and procedures on cleaning during their inspections to ensure that no carryover, contamination or cross contamination from previous products and any other means, is adulterated the subjected drug under inspection. So it is important to any organization to have a cleaning validation program that is scientifically sound and it should give the assurance that the cleaning is performed using a validated procedure and previous product residues are reduced to an acceptable level. This review includes the fundamental and most important aspects involved in the design of a cleaning validation. The job of Cleaning Validation is to prove that the cleaning Procedure consistently removes the previous product down to acceptable levels and the cleaning does not contribute to unacceptable result levels.

Keywords: Cleaning validation, Active pharmaceutical ingredients, Bulk drug, Validation


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