Volume No. 13 Issue No.: 03 Page No.: 269-273 January-March 2019

 

CLEANING ANALYTICAL METHOD VALIDATION

 

Pushpa Agrawal* and Raghu M.G.

Department of Biotechnology, C.M.R.T.U, R.V.College of Engineering Campus, Bangalore, Karnataka (INDIA)

 

Received on : August 14, 2018

 

ABSTRACT

 

In pharmaceutical industry, the main purpose of cleaning validation is to enhance the efficiency and consistency of cleaning process in pharmaceutical production equipment or to avoid cross contamination due to incorrect cleaning of equipment, apparatus, processing area or the starting material, this will result in severe risks for the consumers. So it is required to validate the cleaning procedures to ensure safety, quality, efficacy of the next batches of drug product and regulatory requirements in finished product manufacturing units. By proper cleaning of equipment, apparatus as well as the processing area contamination can be minimized. Pharmaceutical manufacturing companies need to validate their cleaning process to make sure compliance with cGMP regulations. The collective data used to conclude the success of a cleaning validation is built upon both the effective assessment of the manufacturing plant and the robustness of the validated analytical method. In order to ensure the safety of the consumer, there must be a high degree of assurance in the results obtained by analytical methods in order to confirm the absence of residues at the predefined limits on the different equipment surfaces. This review focused on the different types of parameters performed in cleaning analytical method validation adapted by pharmaceutical industry.

 

Keywords : Cleaning validation, Analytical method, Swab, Rinse, Cleaning limit

 

 

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