Server for integrated pharmaceutical analysis and report generation service, method of integrated pharmaceutical manufacturing and research and development numerical analysis, and computer readable recording medium

• US 8,868,225 B2
• Filed: 05/06/2011
• Issued: 10/21/2014
• Est. Priority Date: 05/07/2010
• Status: Active Grant

• Current Assignee: Taiwan Biotech Co. Ltd. (National Express Group Plc /Private Group/)
• Original Assignee: Taiwan Biotech Co. Ltd. (National Express Group Plc /Private Group/)
• Inventors: Lee, Yung-Jin, Wang, Ching-Feng, Chen, Hung-Liang, Chiu, Ju-Min
• Primary Examiner(s): SHECHTMAN, SEAN P
• Application Number:
  US13/102,818
• Publication Number:
  US 20110276161A1
• Time in Patent Office: 1,264 Days
• Field of Search: None
• US Class Current: 700/97
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients

Abstract

A web-based tool (as a server) for integrated pharmaceutical analysis and report generation service is provided in the present invention. The server can be used for numerical analysis and report generation for pharmaceutical manufacturing, research and development, and has advantages such as simple operation, complicated but fast calculation and professional report generation, and high accuracy. The server includes at least one pharmaceutical manufacturing and research and development numerical analysis system configured to perform different pharmaceutical manufacturing and research and development numerical analyses and generate different reports. Each of the at least one pharmaceutical manufacturing and research and development numerical analysis system includes an input module configured to receive, via a user interface, at least one of a template file and a backup file previously output by the server as at least one input file, wherein the at least one input file includes a plurality of data fields to provide corresponding data; at least one calculation module, each configured to execute a built-in pharmaceutical manufacturing and research and development numerical analysis calculation program, thereby automatically performing a pharmaceutical manufacturing and research and development numerical analysis calculation on at least one of the data of the at least one input file and on-line filled data; and an output module configured to generate at least one of a backup file and a report file as at least one output file based on the result of the pharmaceutical manufacturing and research and development numerical analysis calculation performed by the at least one calculation module and provide the at least one file via the user interface.

Claims

1. A server for integrated pharmaceutical analysis and report generation service, comprising:

at least one pharmaceutical manufacturing and research and development numerical analysis system, configured to perform different pharmaceutical manufacturing and research and development numerical analyses, wherein each of the at least one pharmaceutical manufacturing and research and development numerical analysis system comprises;

an input module configured to receive, via a user interface, a first backup file previously generated by the pharmaceutical manufacturing and research and development numerical analysis system as at least one input file, wherein the at least one input file comprises a plurality of data fields to provide corresponding data, wherein no calculation mode or procedure is set or assigned via the user interface, and wherein the data fields of the at least one input file comprise at least one of production line information, equipment information, and pharmaceutical information;

at least one calculation module configured to execute a built-in pharmaceutical manufacturing and research and development numerical analysis calculation program corresponding to at least one of the plurality of data fields of the at least one input file, thereby automatically performing a pharmaceutical manufacturing and research and development numerical analysis calculation on at least one of the data of the at least one input file and data entered online; and

an output module configured to generate a second backup file as at least one output file based on a result of the pharmaceutical manufacturing and research and development numerical analysis performed by the at least one calculation module, and provide the at least one output file via the user interface.

2. The server for integrated pharmaceutical analysis and report generation service according to claim 1, wherein the server for integrated pharmaceutical analysis and report generation service is a network server located at a server side, and the user interface is a web page interface located at a client.

3. The server for integrated pharmaceutical analysis and report generation service according to claim 1, further comprising a data register for registering data associated with a user when the user logs in and removing the data associated with the user when the user logs out.

4. The server integrated pharmaceutical analysis and report generation service according to claim 3, further comprising a backup module for backing up at least a part of data in the data register as the first backup file and providing the first backup file via the user interface.

5. The server for integrated pharmaceutical analysis and report generation service according to claim 1, wherein the at least one pharmaceutical manufacturing and research and development numerical analysis system comprises a pharmaceutical production line cleaning validation system comprising the at least one calculation module, the pharmaceutical manufacturing and research and development numerical analysis calculation performed by the at least one calculation module in the pharmaceutical production line cleaning validation system comprises performing at least one of the following procedures on a plurality of pharmaceuticals on each of at least one production line:

calculating minimum allowable residual quantity values between the pharmaceuticals;

screening an index pharmaceutical from the pharmaceuticals; and

analyzing a suggested production schedule of the pharmaceuticals.

6. The server for integrated pharmaceutical analysis and report generation service according to claim 5, wherein the pharmaceutical production line cleaning validation system further comprises a management module configured to perform at least one of production line information management, equipment information management, and pharmaceutical information management.

7. The server for integrated pharmaceutical analysis and report generation service according to claim 1, wherein the at least one pharmaceutical manufacturing and research and development numerical analysis system comprises a pharmaceutical stability test analysis system configured to analyze and calculate a shelf-life of pharmaceuticals, the pharmaceutical stability test analysis system comprising the at least one calculation module.

8. The server for integrated pharmaceutical analysis and report generation service according to claim 7, wherein the at least one calculation module in the pharmaceutical stability test analysis system comprises at least one of the following modules:

an experimental specification setting module, configured to set a specification data of a stability test of the pharmaceuticals, wherein the stability test comprises at least one test of an experimental item;

an experimental numerical calculation module, configured to determine, based on the specification data of the stability test of the pharmaceuticals and individual experimental result data in at least one experimental period, individual numerical analysis data of the pharmaceuticals in the at least one experimental period;

an experimental data summarization module, configured to determine complete numerical analysis data of the pharmaceuticals in a complete experimental period of the stability test according to the individual numerical analysis data of the pharmaceuticals in at least one experimental period; and

a statistical analysis module, configured to calculate the shelf life of the pharmaceuticals according to the complete numerical analysis data in the complete experimental period of the stability test.

9. The server for integrated pharmaceutical analysis and report generation service according to claim 8, wherein

the experimental data summarization module outputs the complete numerical analysis data to the output module;

the output module generates at least one of the second backup file and a report file according to the complete numerical analysis data; and

the input module receives the second backup file as the input file to provide the statistical analysis module when a user logs in another time.

10. The server for integrated pharmaceutical analysis and report generation service according to claim 7, wherein

the at least one calculation module in the pharmaceutical stability test analysis system is a data and statistical analysis module configured to calculate the shelf-life of the pharmaceutical according to the complete numerical analysis data in the complete experimental period of a stability test;

and

the input module receives the input file via the user interface, and the input file has the complete numerical analysis data and is provided to the data and statistical analysis module as the input file.

11. The server for integrated pharmaceutical analysis and report generation service according to claim 8, wherein the specification data comprises:

at least one of individual experimental type data, individual experimental time data, individual storage condition data, and individual packaging condition data of the at least one experimental item.

12. The server for integrated pharmaceutical analysis and report generation service according to claim 8, wherein the complete numerical analysis data of the pharmaceutical in the complete experimental period is associated with at least one of a selected storage condition and a selected packaging condition.

13. The server for integrated pharmaceutical analysis and report generation service according to claim 8, wherein the individual numerical analysis data in the at least one experimental period comprises at least one of standard concentration data, sample concentration data, principal component content data, impurity content data, dissolution data, relative standard deviation value data, uniformity data, and test result data of the pharmaceuticals.

14. The server for integrated pharmaceutical analysis and report generation service according to claim 1, wherein the at least one pharmaceutical manufacturing and research and development numerical analysis system comprises a pharmaceutical analysis method validation system configured to obtain at least one characteristic analysis data of a pharmaceutical according to experimental result data of the pharmaceutical, the pharmaceutical analysis method validation system comprising the at least one calculation module.

15. The server for integrated pharmaceutical analysis and report generation service according to claim 14, wherein the at least one calculation module in the pharmaceutical analysis method validation system comprises at least one of the following characteristic analysis modules:

a specificity analysis module, a linearity/range analysis module, an accuracy analysis module, a repeatability analysis module, a precision analysis module, a system applicability analysis module, a minimum detectable concentration analysis module, and a minimum quantitative concentration analysis module.

16. The server for integrated pharmaceutical analysis and report generation service according to claim 15, wherein the pharmaceutical analysis method validation system further comprises:

a basic data module, configured to read at least one of an input file containing analysis item data and on-line filled data, wherein the analysis item data is used to designate at least one characteristic analysis item to be performed; and

a characteristic assignment module, configured to identify an attribute of the at least one input file received by the input module, wherein the at least one input file is respectively associated with the at least one characteristic analysis item, and assigned to the corresponding one of the at least one characteristic analysis module according to the identified attribute of the at least one input file.

17. The server for integrated pharmaceutical analysis and report generation service according to claim 1, wherein the input module is configured to receive, via the user interface, a template file as the at least one input file, and wherein the output module is configured to generate a report file as the at least one output file.

18. A method of integrated pharmaceutical manufacturing and research and development numerical analysis, comprising:

performing at least one pharmaceutical manufacturing and research and development numerical analysis procedure, wherein each of the at least one pharmaceutical manufacturing and research and development numerical analysis procedure comprises;

receiving, via a user interface, a first backup file previously output by the pharmaceutical manufacturing and research and development numerical analysis procedure as at least one input file, wherein the at least one input file comprises a plurality of data fields to provide corresponding data, wherein no calculation mode or procedure is set or assigned via the user interface, and wherein the data fields of the at least one input file contain at least one of production line information, equipment information, and pharmaceutical information;

executing a built-in pharmaceutical manufacturing and research and development numerical analysis calculation program corresponding to at least one of the plurality of data fields of the at least one input file, thereby automatically performing a pharmaceutical manufacturing and research and development numerical analysis calculation on at least one of the data of the at least one input file and data entered online; and

generating a second backup file as at least one output file based on a result of the pharmaceutical manufacturing and research and development numerical analysis calculation, and providing the at least one output file via the user interface.

19. The method of integrated pharmaceutical manufacturing and research and development numerical analysis according to claim 18, wherein the method of integrated pharmaceutical manufacturing and research and development numerical analysis is implemented at a server side, and the user interface is a webpage interface located at a client.

20. The method of integrated pharmaceutical manufacturing and research and development numerical analysis according to claim 18, further comprising registering data associated with a user when the user logs in and removing the data associated with the user when the user logs out.

21. The method of integrated pharmaceutical manufacturing and research and development numerical analysis according to claim 18, further comprising backing up at least a part of data in the data associated with the user as the first backup file and providing the first backup file via the user interface.

22. The method of integrated pharmaceutical manufacturing and research and development numerical analysis according to claim 18, wherein the at least one pharmaceutical manufacturing and research and development numerical analysis procedure is a cleaning validation procedure, and the cleaning validation procedure comprises performing at least one of the following steps on a plurality of pharmaceuticals on each of at least one production line:

calculating minimum allowable residual quantity values between the pharmaceuticals;

screening an index pharmaceutical from the pharmaceuticals; and

analyzing a suggested production schedule of the pharmaceuticals.

23. The method of integrated pharmaceutical manufacturing and research and development numerical analysis according to claim 22, wherein the data fields of the at least one input file contain at least one of production line information, equipment information, and pharmaceutical information.

24. The method of integrated pharmaceutical manufacturing and research and development numerical analysis according to claim 18, wherein the at least one pharmaceutical manufacturing and research and development numerical analysis calculation is a stability test analysis procedure for analyzing and calculating a shelf-life of the pharmaceuticals.

25. The method of integrated pharmaceutical manufacturing and research and development numerical analysis according to claim 24, wherein the stability test analysis procedure comprises at least one of the following steps:

setting a specification data of the stability test of the pharmaceuticals, wherein the stability test comprises at least one experimental item;

performing numerical operation according to the specification data of the stability test of the pharmaceuticals and individual experimental result data in at least one experimental period, thereby obtaining individual numerical analysis data of the pharmaceuticals in the at least one experimental period;

obtaining by summarization the complete numerical analysis data of the pharmaceuticals in a complete experimental period of the stability test according to individual numerical analysis data of the pharmaceutical in at least one experimental period; and

calculating the shelf life of the pharmaceutical according to the complete numerical analysis data in the complete experimental period of a stability test.

26. The method of integrated pharmaceutical manufacturing and research and development numerical analysis according to claim 25, wherein the stability test analysis procedure further comprises:

outputting the complete numerical analysis data after obtaining by summarization the complete numerical analysis data;

generating at least one of the second backup file and a report file according to the complete numerical analysis data; and

receiving the second backup file as the input file when a user logs in another time, so as to calculate the shelf life of the pharmaceutical according to the complete numerical analysis data in the second backup file.

27. The method of integrated pharmaceutical manufacturing and research and development numerical analysis according to claim 24, wherein the stability test analysis procedure comprises:

receiving the input file having a complete numerical analysis data in a complete experimental period of a stability test via the user interface, and using the input file as the input file; and

calculating the shelf life of the pharmaceutical according to the complete numerical analysis data in the received input file.

28. The method of integrated pharmaceutical manufacturing and research and development numerical analysis according to claim 25, wherein the specification data comprises:

at least one of individual experimental type data, individual experimental time data, individual storage condition data, and individual packaging condition data of the at least one experimental item.

29. The method of integrated pharmaceutical manufacturing and research and development numerical analysis according to claim 25, wherein the complete numerical analysis data of the pharmaceutical in the complete experimental period is associated with at least one of a selected storage condition and a selected packaging condition.

30. The method of integrated pharmaceutical manufacturing and research and development numerical analysis according to claim 25, wherein the individual numerical analysis data in the at least one experimental period comprises at least one of standard concentration data, sample concentration data, principal component content data, impurity content data, dissolution data, relative standard deviation value data, uniformity data, and test result data of the pharmaceutical.

31. The method of integrated pharmaceutical manufacturing and research and development numerical analysis according to claim 18, wherein the at least one pharmaceutical manufacturing and research and development numerical analysis procedure is an analysis method validation procedure for obtaining at least one characteristic analysis data of the pharmaceuticals according to experimental result data of the pharmaceutical.

32. The method of integrated pharmaceutical manufacturing and research and development numerical analysis according to claim 31, wherein the analysis method validation procedure comprises at least one of the following characteristic analysis steps:

a specificity analysis step, a linearity/range analysis step, an accuracy analysis step, a repeatability analysis step, a precision analysis step, a system applicability analysis step, a minimum detectable concentration analysis step, and a minimum quantitative concentration analysis step.

33. The method of integrated pharmaceutical manufacturing and research and development numerical analysis according to claim 32, wherein the analysis method validation procedure further comprises:

reading at least one of an input file containing analysis item data and data entered online, wherein the analysis item data is used to designate at least one characteristic analysis item to be performed; and

identifying an attribute of the at least one input file received by the input module, wherein the at least one input file is respectively associated with the at least one characteristic analysis item and assigned to the corresponding one of the at least one characteristic analysis step according to the identified attribute of the at least one input file.

34. A non-transitory computer readable recording medium, configured to store a plurality of instructions configured to, when executed by a computing device, enable the computing device to perform the method of claim 18.

35. The method of integrated pharmaceutical manufacturing and research and development numerical analysis according to claim 18, further comprising receiving, via the user interface, a template file as the at least one input file, and generating a report file as the at least one output file.