Manufacturing execution system for validation, quality and risk assessment and monitoring of pharamceutical manufacturing processes
First Claim
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1. ) A method of integrating a computer product with a liquid mixing system said method comprising, a) contacting the computer product to a device used in a liquid mixing process;
- b) monitoring the data generated by the device used in liquid mixing process;
c) maintaining the data over time to provide a historical record;
d) analyzing the historical record to provide a risk-based assessment in case of failure;
e) taking corrective action to obviate the failure.
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Abstract
Manufacturing execution systems relating to methods, systems, and software program for validation of pharmaceutical manufacturing processes and quality assurance process are described and disclosed herein. Consequently, the methods provide a means to perform validation on an integrated level whereby the quality control unit can ensure data and product integrity and minimize cost.
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Citations
26 Claims
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1. ) A method of integrating a computer product with a liquid mixing system said method comprising,
a) contacting the computer product to a device used in a liquid mixing process; -
b) monitoring the data generated by the device used in liquid mixing process;
c) maintaining the data over time to provide a historical record;
d) analyzing the historical record to provide a risk-based assessment in case of failure;
e) taking corrective action to obviate the failure. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. ) A method of integrating a computer product with a powder blending system said method comprising, a) contacting the computer product to a device used in a powder blending process;
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b) monitoring the data generated by the device used in powder blending process;
c) maintaining the data over time to provide a historical record;
d) analyzing the historical record to provide a risk-based assessment in case of failure;
e) taking corrective action to obviate the failure. - View Dependent Claims (9, 10, 11, 12, 13, 14)
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15. ) A method of integrating a computer product with a water-based system said method comprising,
a) contacting the computer product to a device used in a water-based process; -
b) monitoring the data generated by the device used in water-based process;
c) maintaining the data over time to provide a historical record;
d) analyzing the historical record to provide a risk-based assessment in case of failure;
e) taking corrective action to obviate the failure. - View Dependent Claims (16, 17, 18, 19, 20, 21)
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22. ) A method of integrating a computer product with a finishing and packaging system said method comprising,
a) contacting the computer product to a device used in a finishing and packaging process; -
b) monitoring the data generated by the device used in finishing and packaging process;
c) maintaining the data over time to provide a historical record;
d) analyzing the historical record to provide a risk-based assessment in case of failure;
e) taking corrective action to obviate the failure. - View Dependent Claims (23, 24, 25)
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26. ) A pharmaceutical manufacturing execution system by the process comprising,
a) integrating a plurality of devices used in pharmaceutical manufacturing with a computer product; -
b) monitoring the data generated by said devices;
c) maintaining the data over time to provide a historic record;
d) providing a risk-based assessment in case of failure;
taking corrective action to obviate the failure.
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Specification