Manufacturing execution system for validation, quality and risk assessment and monitoring of pharmaceutical manufacturing processes
AssigneeSMP Logic Systems LLC
InventorShane M. Popp
Life of this patent
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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.
Claims23
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.
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.
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.
Dependencies are inferred from the claim text.