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

• US 20070032897A1
• Filed: 10/10/2006
• Published: 02/08/2007
• Est. Priority Date: 05/06/2004
• Status: Active Grant

• Current Assignee: SMP Logic Systems LLC
• Original Assignee: SMP Logic Systems LLC
• Inventors: Popp, Shane
• Granted Patent: US 7,379,784 B2
• Time in Patent Office: Days
• US Class Current: 700/110
• 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 operational system said method comprising,

a) contacting the computer product to a device used in a operational process;

b) monitoring the data generated by the device used in operational process;

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 device is software.

3. ) The method of claim 1, wherein the device is hardware.

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

5. ) The method of claim 1, whereby the integration occurs at end process.

6. ) The method of claim 1, wherein the monitoring is part of routine maintenance.

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

8. ) The operational system of claim 1, wherein the operational system is selected from the group consisting of motors, drives, compressed air systems, HVAC, boilers, and back-up generators.

9. ) A method of integrating a computer product with a cell culture system said method comprising,

a) contacting the computer product to a device used in a cell culture process;

b) monitoring the data generated by the device used in cell culture process;

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.

10. ) The method of claim 9, wherein the device is software.

11. ) The method of claim 9, wherein the device is hardware.

12. ) The method of claim 9, whereby the integration occurs at initial process.

13. ) The method of claim 9, whereby the integration occurs at end process.

14. ) The method of claim 9, wherein the monitoring is part of routine maintenance.

15. ) The method of claim 9, wherein the data is generated by a analysis selected from the group consisting of hazard, boundary value, branch, block check, control flow, and path.

16. ) A method of integrating a computer product with a field instrumentation component said method comprising,

a) contacting the computer product to a device used in a field instrumentation process;

b) monitoring the data generated by the device used in field instrumentation process;

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.

17. ) The method of claim 16, wherein the device is software.

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

19. ) The method of claim 16, whereby the integration occurs at initial process.

20. ) The method of claim 16, whereby the integration occurs at end process.

21. ) The method of claim 16, wherein the monitoring is part of routine maintenance.

22. ) The method of claim 16, wherein the data is generated by a analysis selected from the group consisting of hazard, boundary value, branch, block check, control flow, and path.

23. ) The operational system of claim 16, wherein the operational system is selected from the group consisting of calibration tools, flow meters, intrinsic safety devices, leveling components, weighting components, process analyzers, thermometers, and valves.