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

• US 7,509,185 B2
• Filed: 08/14/2006
• Issued: 03/24/2009
• 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.
• Primary Examiner(s): DeCady; Albert
• Assistant Examiner(s): Garland; Steven R
• Application Number:
  US11/503,800
• Publication Number:
  US 20060276923A1
• Time in Patent Office: 953 Days
• Field of Search: 700/109, 700/110, 700/26, 705 1- 3, 705/7
• 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 integrating a computer product with a pharmaceutical manufacturing software system for manufacturing of pharmaceuticals and validation of pharmaceutical manufacturing processes and quality assurance processes are described and disclosed herein. Consequently, the methods provide a means to manufacture pharmaceuticals on an integrated level whereby the manufacturer can ensure data and product integrity and minimize cost.

Claims

1. A method of integrating a computer memory having computer executable instructions with a pharmaceutical manufacturing device, and taking corrective action said method comprising,

a) integrating by contacting the computer memory having computer executable instructions to said device used in pharmaceutical manufacture;

b) monitoring data generated by said device during pharmaceutical manufacture;

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

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

e) taking corrective action during pharmaceutical manufacturing to obviate the failure, said corrective action comprises modifying said pharmaceutical manufacture.

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

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

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

5. The method of claim 1, wherein the data is generated by an analysis selected from the group consisting of “

boundary value analysis”

, “

branch analysis”

, “

control flow analysis”

, “

failure analysis”

, and “

path analysis”

.