Methods of performing path analysis on pharmaceutical manufacturing systems

• US 7,428,442 B2
• Filed: 04/12/2007
• Issued: 09/23/2008
• 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.
• Primary Examiner(s): DeCady; Albert
• Assistant Examiner(s): Garland; Steven R
• Application Number:
  US11/786,722
• Publication Number:
  US 20070198116A1
• Time in Patent Office: 530 Days
• Field of Search: 700/117, 700/110, 700/108, 700/109, 705 1- 3
• 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 performing path analysis on pharmaceutical manufacturing systems 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 a pharmaceutical manufacturing system, said method comprising,

a) deriving an algorithm implemented in computer executable instructions that performs a “

path analysis”

on a computer program used in a pharmaceutical manufacturing system;

b) performing “

logic analysis”

on said algorithm;

c) integrating said algorithm implemented in computer executable instructions into a pharmaceutical manufacturing system to determine a pharmaceutical manufacturing system path;

d) monitoring said pharmaceutical manufacturing system.

2. The method of claim 1, wherein the pharmaceutical manufacturing occurs in a clinical manufacturing process.

3. The method of claim 1, wherein the pharmaceutical manufacturing occurs in a commercial manufacturing process.

4. The method of claim 1, further comprising using a pharmaceutical manufacturing hardware system having at least a chromatography/separation system.

5. The method of claim 1, further comprising using a pharmaceutical manufacturing system having at least a time-stamped audit trail.

6. A kit comprising a computer memory having computer executable instructions of claim 1.

7. The method of claim 1, wherein said pharmaceutical manufacturing process comprises a “

critical control point”

.

8. The method of claim 1, wherein said pharmaceutical manufacturing process produces an in-process material.

9. The method of claim 8, wherein said in-process material is selected from the group consisting of a component, an active ingredient, and a drug product.