Manufacturing execution system for validation, quality and risk assessment and monitoring of pharmaceutical manufacturing processes
First Claim
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1. A method of integrating a computer product with a pharmaceutical manufacturing crystallization system said method comprising,a) contacting the computer product to a crystallization system used in a pharmaceutical manufacturing process;
- b) monitoring data generated by the crystallization system;
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
28 Claims
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1. A method of integrating a computer product with a pharmaceutical manufacturing crystallization system said method comprising,
a) contacting the computer product to a crystallization system used in a pharmaceutical manufacturing process; -
b) monitoring data generated by the crystallization system; 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, 6, 7)
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5. (canceled)
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8. A method of integrating a computer product with a pharmaceutical manufacturing tablet press system said method comprising,
a) contacting the computer product to a tablet press system used in a pharmaceutical manufacturing process; -
b) monitoring data generated by the tablet press system; 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, 13, 14)
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12. (canceled)
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15. A method of integrating a computer product with a pharmaceutical manufacturing chromatography system said method comprising,
a) contacting the computer product to a chromatography system used in a pharmaceutical manufacturing process; -
b) monitoring data generated by the chromatography system; 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, 20, 21)
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19. (canceled)
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22. A method of integrating a computer product with a pharmaceutical manufacturing pH system said method comprising,
a) contacting the computer product to a pH system used in a pharmaceutical manufacturing process; -
b) monitoring data generated by the pH system; 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, 27, 28)
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26. (canceled)
Specification