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Simultaneous Development and Validation of Analytical Methods for Cleaning Samples Analysis of Gliclazide and Meslamine in Pharmaceutical Industry Singh Ashish, Sharma Pushpendra University Teaching Department, Sri Satya Sai University of Technology and Medical Sciences, Pachama, Sehore-466001, India Corresponding Author E-mail: om11agra85@gmail.com
Online published on 19 December, 2019. Abstract The present study involved implementation of a cleaning validation program that was simple, easy to implement and adequate to reduce concentrations of the previous product and detergent to levels which are acceptable in terms of safety and purity of the product manufactured also to the regulatory authorities. A worst-case approach was utilized in which one reference product out of the group manufactured in particular equipment was chosen for validation. The reference product selected from the group was one which was most difficult to clean based on the product's water solubility, as well as practical experience in cleaning that product. A worst-case criterion was applied to this product using MACO (maximum allowable carry-over) calculation to arrive at the acceptance criteria. Top Keywords Cleaning Validation, Pharmaceutical Industry, MACO (Maximum Allowable Carry over), Method Validation. Top | |
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