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US 2016/0041551 A1Published application
Methods for monitoring integrated continuous pharmacetical manufacturing processes
OwnerShane M. Poppinventor
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Abstract
Methods for monitoring integrated continuous pharmaceutical manufacturing processes are described and disclosed herein. The method continuously monitors and creates a historic record of the pharmaceutical manufacturing process and provides it to an end user or a plurality of end users. Consequently, the methods provide a means to perform quality control on an integrated level whereby a pharmaceutical manufacturer can ensure data and product integrity and minimize cost.
Claims19
1) A method comprising,
- a) continuously monitoring an acceptance criteria in a pharmaceutical manufacturing process, where said pharmaceutical manufacturing process produces an active ingredient and wherein the monitoring occurs at a critical control point;
- b) compiling data obtained during the monitoring of the pharmaceutical manufacturing process and storing the data in a historic record, wherein the historic record comprises a lot number, control number, or batch number;
- c) analyzing the historic record to provide a comparative analysis against the acceptance criteria, wherein the analysis is performed at various times throughout the pharmaceutical manufacturing production cycle;
- d) taking corrective action during the pharmaceutical manufacturing process based on a comparative analysis against the acceptance criteria, wherein said corrective action comprises modifying the pharmaceutical manufacturing process.
1 more element
11) A method comprising,
- a) continuously monitoring data generated by a pharmaceutical chromatography/separation system, wherein said chromatography/separation system produces a drug product;
- b) maintaining the data over time to provide a historic record;
- c) analyzing the historic record to provide a quality assurance determination for said drug product;
- d) taking corrective action to obviate a failure against said quality assurance determination.
1 more element
Dependencies are inferred from the claim text.