MUMBAI, India, Jan. 2 -- Intellectual Property India has published a patent application (202541123207 A) filed by Vellore Institute Of Technology, Vellore, Tamil Nadu, on Dec. 6, 2025, for 'quality management system deviation handling with structured timeline framework.'
Inventor(s) include Dr. Danie Kingsley J; and R Samyuktha Kanth.
The application for the patent was published on Jan. 2, under issue no. 01/2026.
According to the abstract released by the Intellectual Property India: "The present disclosure provides a method for deviation handling in a quality management system for pharmaceutical manufacturing. The method (100, 200, 300) includes identifying (102, 202, 302) deviations in pharmaceutical manufacturing operations, categorizing (106) the deviations by severity level into at least two categories based on potential impact on product quality and regulatory compliance, and determining (108) a processing pathway based on severity classification. For higher severity deviations, the method includes conducting (110, 204) a comprehensive impact assessment within a first predefined timeframe and performing (114) detailed root cause analysis using structured analytical tools. For lower severity deviations, the method includes conducting (112, 304) a basic impact assessment within a second predefined timeframe shorter than the first predefined timeframe and performing (116) simplified root cause analysis. The method further includes implementing (126, 128) corrective and preventive actions based on investigation findings."
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