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 operational unit said method comprising,a) monitoring data generated by an operational unit 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.
164 Citations
23 Claims
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1. A method of monitoring an acceptance criteria of a pharmaceutical manufacturing operational unit said method comprising,
a) monitoring data generated by an operational unit 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, 8)
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9. A method of monitoring an acceptance criteria of a cell culture system said method comprising,
a) monitoring data generated by a cell culture 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 (10, 11, 12, 13, 14, 15)
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16. A method of monitoring an acceptance criteria of a pharmaceutical manufacturing field instrumentation component said method comprising,
a) monitoring data generated by a field instrumentation component 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 (17, 18, 19, 20, 21, 22, 23)
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