Monitoring acceptance criteria of pharmaceutical manufacturing processes

• US 8,591,811 B2
• Filed: 03/18/2013
• Issued: 11/26/2013
• 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.
• Primary Examiner(s): Nagpaul, Jyoti
• Application Number:
  US13/815,713
• Publication Number:
  US 20130218317A1
• Time in Patent Office: 253 Days
• Field of Search: 422 64- 67, 436/180, 700/26, 700109-110
• US Class Current: 422/67
• 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

Methods of monitoring acceptance criteria of pharmaceutical manufacturing processes are disclosed herein. The methods described herein provide an ability to control and monitor pharmaceutical manufacturing processes (for example, finishing and packaging of pharmaceuticals) and can ensure data and product integrity and ultimately minimize overall manufacturing cost.

Claims

1. A method of monitoring an acceptance criteria of a pharmaceutical manufacturing system said method comprising,

a) monitoring data generated by a pharmaceutical manufacturing system during pharmaceutical manufacture, wherein said pharmaceutical manufacture produces an active ingredient;

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 during pharmaceutical manufacture 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 monitoring is part of a quality assurance protocol.

3. The method of claim 1, wherein the historical record comprises a time stamped audit trail.

4. The method of claim 1, wherein the pharmaceutical manufacturing system uses at least a mixing tank and a time-stamped audit trail.

5. The method of claim 1, wherein said monitoring is at initial process.

6. The method of claim 1, wherein said monitoring is at end process.

7. A method comprising,

a) monitoring data generated by a pharmaceutical finishing and packaging system, wherein said finishing and packaging system produces a drug product;

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

c) analyzing the historic record to provide a quality assurance determination for said drug product;

d) taking corrective action to obviate a failure against said quality assurance determination.

8. The method of claim 7, wherein said finishing and packaging system comprises a labeler.

9. The method of claim 7, wherein said finishing and packaging system comprises filling equipment.

10. The method of claim 7, wherein said finishing and packaging system comprises a vision inspection system.

11. The method of claim 7, wherein said finishing and packaging system comprises a capping machine.

12. The method of claim 7, wherein said historic record is maintained in a SQL database.

13. The method of claim 7, wherein said monitoring is continuous.

14. The method of claim 7, wherein said quality assurance determination is based on a quality assurance protocol.