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 batch process and taking corrective action said method comprising,a) monitoring data generated by a pharmaceutical manufacturing batch process during pharmaceutical manufacture wherein said pharmaceutical manufacture produces an in-process material;
- b) maintaining the data over time to provide a historical record, wherein said historic record is associated with a distinct batch number;
c) analyzing the historical record and providing a comparative analysis against an acceptance criteria wherein said acceptance criteria is determined at initial batch process said acceptance criteria comprising product specifications, an acceptable quality level, an unacceptable quality level, with an associated sampling plan;
d) taking corrective action to obviate a rejection determined by the comparative analysis against the acceptance criteria whereby said corrective action comprises modifying said pharmaceutical batch manufacture wherein said pharmaceutical manufacture produces an in-process material.
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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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9 Claims
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1. A method of monitoring an acceptance criteria of a pharmaceutical manufacturing batch process and taking corrective action said method comprising,
a) monitoring data generated by a pharmaceutical manufacturing batch process during pharmaceutical manufacture wherein said pharmaceutical manufacture produces an in-process material; -
b) maintaining the data over time to provide a historical record, wherein said historic record is associated with a distinct batch number; c) analyzing the historical record and providing a comparative analysis against an acceptance criteria wherein said acceptance criteria is determined at initial batch process said acceptance criteria comprising product specifications, an acceptable quality level, an unacceptable quality level, with an associated sampling plan; d) taking corrective action to obviate a rejection determined by the comparative analysis against the acceptance criteria whereby said corrective action comprises modifying said pharmaceutical batch manufacture wherein said pharmaceutical manufacture produces an in-process material. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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