Monitoring liquid mixing systems and water based systems in pharmaceutical manufacturing
First Claim
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1. A method comprising,a) monitoring data generated by a pharmaceutical liquid mixing system, wherein said liquid mixing system produces a drug product;
- b) maintaining the data over time to provide a historical record;
c) analyzing the historical record to provide a quality assurance determination for said drug product;
d) taking corrective action to obviate a failure against said quality assurance determination.
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Abstract
Methods of monitoring pharmaceutical manufacturing processes are disclosed herein. The methods described herein provide an ability to control and monitor pharmaceutical manufacturing processes (for example, liquid mixing systems and water based systems) and can ensure data and product integrity and ultimately minimize overall manufacturing cost.
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19 Claims
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1. A method comprising,
a) monitoring data generated by a pharmaceutical liquid mixing system, wherein said liquid mixing system produces a drug product; -
b) maintaining the data over time to provide a historical record; c) analyzing the historical record to provide a quality assurance determination for said drug product; d) taking corrective action to obviate a failure against said quality assurance determination. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A method comprising,
a) monitoring data generated by a pharmaceutical water based system, wherein said water based system produces a drug product; -
b) maintaining the data over time to provide a historic record; c) analyzing the historic record to provide a quality assurance determination for said drug product; d) taking corrective action to obviate a failure against said quality assurance determination. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18, 19)
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Specification