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.
Claims34
A method of monitoring an acceptance criteria of a pharmaceutical manufacturing crystallization system said method comprising,
- a) monitoring data generated by a crystallization 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 tablet press system said method comprising,
- a) monitoring data generated by a tablet press 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 chromatography system said method comprising,
- a) monitoring data generated by a chromatography 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 pH system said method comprising,
- a) monitoring data generated by a pH 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 a pharmaceutical manufacturing process said method comprising,
- a) contacting a pharmaceutical “manufacturing execution system” to a plurality of devices used to manufacture a pharmaceutical;
- b) monitoring an acceptance criteria of an ingredient used to manufacture said pharmaceutical during each step of pharmaceutical manufacture;
- c) measuring the quality parameters of said ingredient relative to the acceptance criteria during each step of pharmaceutical manufacture;
- d) determining whether to accept or reject said ingredient based on said quality parameter.
Dependencies are inferred from the claim text.