Volume No. :   11

Issue No. :  4

Year :  2019

ISSN Print :  0975-4393

ISSN Online :  2349-2988


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Simultaneous Analytical Methods Development and Validation of for Cleaning Samples Analysis using Total Organic Carbon Analyzer (TOC)



Address:   Ashish Singh, Pushpendra Sharma
University Teaching Department, Sri Satya Sai University of Technology & Medical Sciences, Pachama, Sehore-466001, India.
*Corresponding Author
DOI No: 10.5958/2349-2988.2019.00038.X

ABSTRACT:
Pharmaceuticals produced in a multi-product manufacturing facility can be contaminated by potentially harmful and toxic substances. In such facilities, the equipment is commonly used for manufacturing several different products of varying potencies. Improper equipment cleaning procedures can lead to possible contamination of the products with different types of residues. Although it is theoretically possible to clean equipment to such an extent that it is free from residues of the previous product, this situation is neither practical nor a business-friendly option in today’s competitive environment. The time and cost involved in such cleaning would make it practically impossible to run an economically viable manufacturing unit. The study also included validation of manufacturing unit’s cleaning procedures to demonstrate that the procedures are capable of reducing active ingredient concentrations on equipment surface to levels below the calculated acceptance criteria.
KEYWORDS:
Cleaning Validation, Pharmaceutical Industry, MACO (Maximum Allowable Carry over), Method Validation.
Cite:
Ashish Singh, Pushpendra Sharma. Simultaneous Analytical Methods Development and Validation of for Cleaning Samples Analysis using Total Organic Carbon Analyzer (TOC). Research J. Science and Tech. 2019; 11(4):268-274.
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