Journal :   Asian Journal of Research in Chemistry

Volume No. :   12

Issue No. :  6

Year :  2019

Pages :   326-329

ISSN Print :  0974-4169

ISSN Online :  0974-4150


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Simultaneous Development and Validation of Analytical Methods for Cleaning Samples Analysis of Gliclazide and Meslamine in Pharmaceutical Industry



Address:   Ashish Singh, Pushpendra Sharma
University Teaching Department, Sri Satya Sai University of Technology and Medical Sciences, Pachama, Sehore-466001, India.
*Corresponding Author
DOI No: 10.5958/0974-4150.2019.00060.9

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.
KEYWORDS:
Cleaning Validation, Pharmaceutical Industry, MACO (Maximum Allowable Carry over), Method Validation.
Cite:
Ashish Singh, Pushpendra Sharma. Simultaneous Development and Validation of Analytical Methods for Cleaning Samples Analysis of Gliclazide and Meslamine in Pharmaceutical Industry. Asian J. Research Chem. 2019; 12(6):326-329.
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