Manufacturing execution system for validation, quality and risk assessment and monitoring of pharmaceutical manufacturing processes
DCFirst Claim
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1. A method of monitoring an acceptance criteria of a pharmaceutical manufacturing liquid mixing system said method comprising,a) monitoring data generated by a liquid mixing system during pharmaceutical manufacture;
- b) maintaining the data over time to provide a historical record;
c) analyzing the historical record to provide a comparative analysis against an acceptance criteria;
d) taking corrective action during pharmaceutical manufacture to obviate a rejection against the acceptance criteria whereby said corrective action comprises modifying said pharmaceutical manufacture.
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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 monitoring an acceptance criteria of a pharmaceutical manufacturing liquid mixing system said method comprising,
a) monitoring data generated by a liquid mixing system during pharmaceutical manufacture; -
b) maintaining the data over time to provide a historical record; c) analyzing the historical record to provide a comparative analysis against an acceptance criteria; d) taking corrective action during pharmaceutical manufacture to obviate a rejection against the acceptance criteria whereby said corrective action comprises modifying said pharmaceutical manufacture. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A method of monitoring an acceptance criteria of a pharmaceutical manufacturing powder blending system said method comprising,
a) monitoring data generated by a powder blending system during pharmaceutical manufacture; -
b) maintaining the data over time to provide a historical record; c) analyzing the historical record to provide a comparative analysis against an acceptance criteria; d) taking corrective action during pharmaceutical manufacture to obviate a rejection against the acceptance criteria whereby said corrective action comprises modifying said pharmaceutical manufacture. - View Dependent Claims (9, 10, 11, 12, 13, 14)
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15. A method of monitoring an acceptance criteria of a pharmaceutical manufacturing water-based system said method comprising,
a) monitoring data generated by a water-based system during pharmaceutical manufacture; -
b) maintaining the data over time to provide a historical record; c) analyzing the historical record to provide a comparative analysis against an acceptance criteria; d) taking corrective action during pharmaceutical manufacture to obviate a rejection against the acceptance criteria whereby said corrective action comprises modifying said pharmaceutical manufacture. - View Dependent Claims (16, 17, 18, 19, 20, 21)
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22. A method of monitoring an acceptance criteria of a pharmaceutical manufacturing finishing and packaging system said method comprising,
(a) monitoring data generated by a finishing and packaging system during pharmaceutical manufacture; -
(b) maintaining the data over time to provide a historical record; (c) analyzing the historical record to provide a comparative analysis against an acceptance criteria; (d) taking corrective action during pharmaceutical manufacture to obviate a rejection against the acceptance criteria whereby said corrective action comprises modifying said pharmaceutical manufacture. - View Dependent Claims (23, 24, 25)
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26. A pharmaceutical “
- manufacturing execution system”
by a process comprising,a) integrating a plurality of hardware or software devices used in pharmaceutical manufacturing with a computer memory having computer executable instructions; b) monitoring data generated by said devices during pharmaceutical manufacture; c) maintaining the data over time to provide a historic record; d) analyzing said data to make a quality assessment of said pharmaceutical manufacture.
- manufacturing execution system”
Specification