Manufacturing execution system for validation, quality and risk assessment and monitoring of pharmaceutical manufacturing processes
DCFirst Claim
Patent Images
1. 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.
1 Assignment
Litigations
0 Petitions
Accused Products
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.
-
Citations
34 Claims
-
1. 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. - View Dependent Claims (2, 3, 4, 5, 6, 7)
-
-
8. 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. - View Dependent Claims (9, 10, 11, 12, 13, 14)
-
-
15. 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. - View Dependent Claims (16, 17, 18, 19, 20, 21)
-
-
22. 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. - View Dependent Claims (23, 24, 25, 26, 27, 28)
-
-
29. 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. - View Dependent Claims (30, 31, 32, 33, 34)
- manufacturing execution system”
Specification