Automation and Validation of Information in Pharmaceutical Processing (Record no. 15070)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 03041nam a2200169Ia 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 140223b1998 xxu||||| |||| 00| 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9780824701192 |
| Terms of availability | 0.00 |
| 082 ## - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 615.39 |
| Item number | AUT |
| 245 ## - TITLE STATEMENT | |
| Title | Automation and Validation of Information in Pharmaceutical Processing |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) | |
| Place of publication, distribution, etc | New York |
| Name of publisher, distributor, etc | Marcel Dekker, Inc. |
| Date of publication, distribution, etc | 1998 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 445p |
| 500 ## - GENERAL NOTE | |
| General note | This thoroughly authoritative work furnishes organizational, technological, validation, project management, and business perspectives on pharmaceutical information automation from industry and system automation professionals-demonstrating how to fulfill computer system validation requirements for hardware, applications, networks, data center operations, and complex software management practices in pharmaceutical manufacturing. Explains how the Food and Drug Administration's latest Good Manufacturing Process guidelines supporting electronic identification and electronic signatures for batch record registration together with computer system technologies will influence pharmaceutical production automation! Designed to provide quick and easy access to a whole range of system development topics, Automation and Validation of Information in Pharmaceutical Processing · defines a complete life-cycle methodology that integrates equipment, people, and information · presents concepts, guidelines, test plans, example forms, and application details for previously unavailable computer system validation of complex automated information systems · introduces, for the first time in depth, PQ testing of integrated manufacturing execution (MES) and manufacturing resource planning (MRP) applications · describes how human resource programs maximize productivity gains for automation initiatives · discusses approaches to automating batch operations with process control systems using industry examples and applicable computer technology concepts · provides an outline for IQ, OQ, and PQ test plans for process control systems, including forms for use in testing instrumentation and distributed control system installation and operations · employs a business analysis standpoint on life-cycle planning to justify new automation projects, including multiyear drug manufacturing plans · documents the successful application of life-cycle methodologies to supply chain functions · and much more! Together with references, tables, and drawings, Automation and Validation of Information in Pharmaceutical Processing is an essential, hands-on resource for pharmaceutical scientists, manufacturers, and engineers; drug quality assurance and regulatory personnel; project and program manufacturers; information system professionals and software developers and analysts; information technology practitioners; and graduate-level and continuing-education students in these disciplines. |
| 600 ## - SUBJECT ADDED ENTRY--PERSONAL NAME | |
| Personal name | Pharmaceutical Industry |
| 9 (RLIN) | 105143 |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| Personal name | deSpautz, Joseph F. |
| Relator term | Editor |
| 9 (RLIN) | 105144 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Dewey Decimal Classification |
| Item type | Book |
| 995 ## - RECOMMENDATION 995 [LOCAL, UNIMARC FRANCE] | |
| Origin of item (home branch) (free text) | Pharmacy Reference |
| Genre | P0002549 |
| Section | 615.39 |
| Recipient parent organisation code | P0002549 |
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