Manufacturing execution system for validation, quality and risk assessment and monitoring of pharmaceutical manufacturing processes

• US 20080038833A1
• Filed: 08/14/2006
• Published: 02/14/2008
• 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 7,799,273 B2
• Time in Patent Office: Days
• US Class Current: 436/161
• CPC Class Codes: G05B 19/41875 characterised by quality surveillance of production
• CPC Class Codes: G05B 2219/11 Plc I-O input output
• CPC Class Codes: G05B 2219/1112 Bit addressing, handling
• CPC Class Codes: G05B 2219/31277 Dispatching rules, shortest travel time or bidding based to reduce empty travel
• CPC Class Codes: G05B 2219/32177 Computer assisted quality surveyance, caq
• 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: G06Q 10/06 Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
• CPC Class Codes: G06Q 50/04 Manufacturing
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: Y02P 90/02 Total factory control, e.g. smart factories, flexible manufacturing systems [FMS] or integrated manufacturing systems [IMS]
• CPC Class Codes: Y02P 90/30 Computing systems specially adapted for manufacturing
• CPC Class Codes: Y02P 90/80 Management or planning
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

Manufacturing execution systems relating to 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 of integrating a computer product with a pharmaceutical manufacturing crystallization system said method comprising,

a) contacting the computer product to a crystallization system used in a pharmaceutical manufacturing process;

b) monitoring data generated by the crystallization system;

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.

2. The method of claim 1, wherein the crystallization system is integrated into a pharmaceutical manufacturing software system.

3. The method of claim 1, wherein the crystallization system is integrated into a pharmaceutical manufacturing hardware system.

4. The method of claim 1, whereby the integration occurs at initial process.

6. The method of claim 1, wherein the monitoring is part of routine maintenance to assure conformance with pharmaceutical manufacturing quality control.

7. The method of claim 1, wherein the data is generated by an analysis selected from the group consisting of failure, boundary value, branch, block check, control flow, failure modes and effects and path.

5. (canceled)

8. A method of integrating a computer product with a pharmaceutical manufacturing tablet press system said method comprising,

a) contacting the computer product to a tablet press system used in a pharmaceutical manufacturing process;

b) monitoring data generated by the tablet press system;

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.

9. The method of claim 8, wherein the tablet press system is integrated into a pharmaceutical manufacturing software system.

10. The method of claim 8, wherein the tablet press system is integrated into a pharmaceutical manufacturing hardware system.

11. The method of claim 8, whereby the integration occurs at initial process.

13. The method of claim 8, wherein the monitoring is part of routine maintenance to assure conformance with pharmaceutical manufacturing quality control.

14. The method of claim 8, wherein the data is generated by an analysis selected from the group consisting of failure, boundary value, branch, block check, control flow, failure modes and effects and path.

12. (canceled)

15. A method of integrating a computer product with a pharmaceutical manufacturing chromatography system said method comprising,

a) contacting the computer product to a chromatography system used in a pharmaceutical manufacturing process;

b) monitoring data generated by the chromatography system;

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.

16. The method of claim 15, wherein the chromatography system is integrated into a pharmaceutical manufacturing software system.

17. The method of claim 15, wherein the chromatography system is integrated into a pharmaceutical manufacturing hardware system.

18. The method of claim 15, whereby the integration occurs at initial process.

20. The method of claim 15, wherein the monitoring is part of routine maintenance to assure conformance with pharmaceutical manufacturing quality control.

21. The method of claim 15, wherein the data is generated by an analysis selected from the group consisting of failure, boundary value, branch, block check, control flow, failure modes and effects and path.

19. (canceled)

22. A method of integrating a computer product with a pharmaceutical manufacturing pH system said method comprising,

a) contacting the computer product to a pH system used in a pharmaceutical manufacturing process;

b) monitoring data generated by the pH system;

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.

23. The method of claim 22, wherein the pH system is integrated into a pharmaceutical manufacturing software system.

24. The method of claim 22, wherein the pH system is integrated into a pharmaceutical manufacturing hardware system.

25. The method of claim 22, whereby the integration occurs at initial process.

27. The method of claim 22, wherein the monitoring is part of routine maintenance to assure conformance with pharmaceutical manufacturing quality control.

28. The method of claim 22, wherein the data is generated by an analysis selected from the group consisting of failure, boundary value, branch, block check, control flow, failure modes and effects and path.

26. (canceled)