Methods, systems, and software program for validation and monitoring of pharmaceutical manufacturing processes
First Claim
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1. ) A method for performing boundary value analysis on a pharmaceutical manufacturing system, said method comprising:
- a) establishing boundary values from data endpoints provided by a quality control unit;
b) deriving an alogorithm that performs boundary value analysis on said pharmaceutical manufacturing process;
c) performing logic analysis on said algorithm;
d) integrating the said algorithm into a pharmaceutical manufacturing process whereby control of said manufacturing process is attained.
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Abstract
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.
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Citations
12 Claims
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1. ) A method for performing boundary value analysis on a pharmaceutical manufacturing system, said method comprising:
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a) establishing boundary values from data endpoints provided by a quality control unit;
b) deriving an alogorithm that performs boundary value analysis on said pharmaceutical manufacturing process;
c) performing logic analysis on said algorithm;
d) integrating the said algorithm into a pharmaceutical manufacturing process whereby control of said manufacturing process is attained. - View Dependent Claims (2, 3, 7, 8, 9, 11)
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4. ) A method of performing a path analysis on a pharmaceutical manufacturing system, said method comprising,
a) establishing a failure benchmark from endpoints provided by a quality control unit; -
b) deriving an alogorithm that performs path analysis on said pharmaceutical manufacturing system;
c) performing logic analysis on said algorithm;
d) integrating the said algorithm into a pharmaceutical manufacturing system whereby control of said manufacturing process is attained. - View Dependent Claims (5, 6, 10, 12)
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Specification