Methods, systems, and software program for validation and monitoring of pharmaceutical manufacturing processes

• US 20060271227A1
• Filed: 08/08/2006
• Published: 11/30/2006
• Est. Priority Date: 05/06/2004
• Status: Active Grant

• Current Assignee: SMP Logic Systems LLC
• Original Assignee: SMP Logic Systems LLC
• Inventors: Popp, Shane M.
• Granted Patent: US 7,471,991 B2
• Time in Patent Office: Days
• US Class Current: 700/110
• CPC Class Codes: G05B 2219/11 Plc I-O input output
• CPC Class Codes: G05B 2219/1112 Bit addressing, handling
• CPC Class Codes: G05B 2223/02 Indirect monitoring, e.g. monitoring production to detect faults of a system
• CPC Class Codes: G05B 23/0224 Process history based detection method, e.g. whereby history implies the availability of large amounts of data
• CPC Class Codes: G05B 23/0235 based on a comparison with predetermined threshold or range, e.g. "classical methods", carried out during normal operation; threshold adaptation or choice; when or how to compare with the threshold
• CPC Class Codes: G06Q 10/06 Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling

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.

Claims

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.

2. ) The method of claim 1, wherein the pharmaceutical manufacturing occurs in a clinical manufacturing process.

3. ) The method of claim 1, wherein the pharmaceutical manufacturing occurs in a post-clinical commercial manufacturing process.

7. ) The method as in either claim 1 or claim 4, in which the analysis is performed on pharmaceutical manufacturing system hardware.

8. ) The method as in either claim 1 or claim 4, in which the analysis is performed on pharmaceutical manufacturing system software.

9. ) A computer product which performs the method according to claim 1.

11. ) A kit comprising the computer product of claim 9.

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.

5. ) The method of claim 4, wherein the pharmaceutical manufacturing occurs in a clinical manufacturing process.

6. ) The method of claim 4, wherein the pharmaceutical manufacturing occurs in a post-clinical commercial manufacturing process.

10. ) A computer product which performs the method according to claim 4.

12. ) A kit comprising the computer product of claim 10.