Methods of monitoring acceptance criteria of pharmaceutical manufacturing processes
First Claim
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1. ) A method of monitoring an acceptance criteria of a pharmaceutical manufacturing process and taking corrective action said method comprising,a) monitoring data generated by a pharmaceutical manufacturing process 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 to obviate a rejection against the acceptance criteria whereby said corrective action comprises modifying said pharmaceutical manufacture.
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Abstract
Methods of monitoring an acceptance criteria of pharmaceutical manufacturing processes are described and disclosed herein. Consequently, the methods provide a means to perform validation and quality control on an integrated level whereby a pharmaceutical manufacturer can ensure data and product integrity and minimize cost.
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Citations
20 Claims
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1. ) A method of monitoring an acceptance criteria of a pharmaceutical manufacturing process and taking corrective action said method comprising,
a) monitoring data generated by a pharmaceutical manufacturing process 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 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, 9, 10, 11, 12, 13, 14)
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15. ) A method of performing quality assurance on a pharmaceutical manufacturing system, said method comprising,
a) deriving an algorithm which performs failure modes and effects analysis on a pharmaceutical manufacturing device; -
b) integrating by contacting said algorithm to said device; c) monitoring data generated by said device during pharmaceutical manufacturing; d) analyzing said data against a predetermined technical requirement for said device; e) determining whether said device conforms to said technical requirement. - View Dependent Claims (16, 17, 18, 19, 20)
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Specification