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

• US 20050251278A1
• Filed: 05/06/2004
• Published: 11/10/2005
• 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 7,444,197 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 monitoring the pharmaceutical manufacturing process, said method comprising:

a) establishing boundary values from endpoints provided by the quality control unit;

b) deriving an alogorithm that performs analysis on said pharmaceutical manufacturing process;

c) performing logic analysis on said algorithm;

d) performing safety code analysis on said algorithm;

e) performing safety design analysis on said algorithm;

f) performing safety requirements analysis on said algorithm;

g) performing said test analysis on said algorithm;

h) integrating the said algorithm into a pharmaceutical manufacturing process whereby said manufacturing process is monitored.

2. ) The method of claim 1, wherein the analysis is selected from the group consisting of boundary value analysis, block check, branch analysis, control flow analysis, failure analysis, and path analysis.

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

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

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

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

5. ) A method of performing a hazard analysis on a pharmaceutical manufacturing system, said method comprising,

a) establishing a failure benchmark from endpoints provided by the quality control unit;

b) deriving an alogorithm that performs analysis on said pharmaceutical manufacturing system;

c) performing logic analysis on said algorithm;

d) performing error detection on said system.

e) integrating the said algorithm into a pharmaceutical manufacturing system whereby said manufacturing process is analyzed.

6. ) The method of claim 5 further comprising, confirming the error detection by error guessing and error seeding.

7. ) The method of claim 5, wherein the analysis is performed on pharmaceutical manufacturing system hardware.

8. ) The method of claim 5, wherein the analysis is performed on pharmaceutical manufacturing system software.

9. ) The method of claim 5, wherein the pharmaceutical manufacturing system is selected from the group consisting of a clinical manufacturing process, a post-clinical commercial manufacturing process, and a quality assurance process.

11. ) A computer product which performs the method according to claim 5.

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

14. ) A method of integrating a computer product with a pharmaceutical manufacturing system said method comprising,

a) contacting the computer product to a device used in pharmaceutical manufacture;

b) monitoring the data generated by the device used in pharmaceutical manufacture;

c) maintaining the data over time to provide a historical record;

d) analyzing the historical record to provide a risk-based assessment in case of failure;

e) taking corrective action to obviate the failure.

15. ) The method of claim 14, wherein the device is software.

16. ) The method of claim 14, wherein the device is hardware.

17. ) The method of claim 14, whereby the integration occurs at initial process.

18. ) The method of claim 14, whereby the integration occurs at end process.

19. ) The method of claim 14, wherein the monitoring is part of routine maintainence.

20. ) The method of claim 14, wherein the data is generated by failure analysis.