Methods of monitoring acceptance criteria of pharmaceutical manufacturing processes

• US 20090143892A1
• Filed: 01/29/2009
• Published: 06/04/2009
• 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 8,660,680 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 of monitoring an acceptance criteria of pharmaceutical manufacturing processes are described and disclosed herein. Consequently, the methods provide a means to perform validation and quality control on an integrated level whereby a pharmaceutical manufacturer can ensure data and product integrity and minimize cost.

Claims

1. ) A method of monitoring an acceptance criteria of a pharmaceutical manufacturing process and taking corrective action said method comprising,

a) monitoring data generated by a pharmaceutical manufacturing process during pharmaceutical manufacture;

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

c) analyzing the historical record to provide a comparative analysis against an acceptance criteria;

d) taking corrective action to obviate a rejection against the acceptance criteria whereby said corrective action comprises modifying said pharmaceutical manufacture.

2. ) The method of claim 1, wherein the pharmaceutical manufacturing process produces an active ingredient.

3. ) The method of claim 1, wherein the pharmaceutical manufacturing process produces an inactive ingredient.

4. ) The method of claim 1, wherein the pharmaceutical manufacturing process produces a component.

5. ) The method of claim 1, wherein the pharmaceutical manufacturing process produces a drug product.

6. ) The method of claim 1, wherein said historic record is associated with a distinct lot number.

7. ) The method of claim 1, wherein said historic record is associated with a distinct control number.

8. ) The method of claim 1, wherein said historic record is associated with a distinct batch number.

9. ) The method of claim 1, wherein the monitoring is continuous.

10. ) The method of claim 1, whereby the monitoring occurs at initial process.

11. ) The method of claim 1, whereby the monitoring occurs at end process.

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

13. ) A computer memory having computer readable instructions which performs the method of claim 1.

14. ) A kit comprising the computer memory having computer readable instructions of claim 13.

15. ) A method of performing quality assurance on a pharmaceutical manufacturing system, said method comprising,

a) deriving an algorithm which performs failure modes and effects analysis on a pharmaceutical manufacturing device;

b) integrating by contacting said algorithm to said device;

c) monitoring data generated by said device during pharmaceutical manufacturing;

d) analyzing said data against a predetermined technical requirement for said device;

e) determining whether said device conforms to said technical requirement.

16. ) The method of claim 15, wherein the monitoring is continuous.

17. ) The method of claim 15, wherein said device is a blender.

18. ) The method of claim 15, wherein said device is a clean-in-place (CIP) system.

19. ) A computer memory having computer readable instructions which performs the method of claim 15.

20. ) A kit comprising the computer memory having computer readable instructions of claim 19.