Automation and Validation of Information in Pharmaceutical Processing: 1st Edition (Hardback) book cover

Automation and Validation of Information in Pharmaceutical Processing

1st Edition

By Joseph F. deSpautz

CRC Press

464 pages

Purchasing Options:$ = USD
Hardback: 9780824701192
pub: 1998-06-16
eBook (VitalSource) : 9780429074981
pub: 1998-06-16
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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.

  • Reviews


    For many workers in the pharmaceutical industry, the present volume will give them more information on the validation aspects of process automation than they ever dreamed possible. However, for those whose lives center around such work, the editor has developed a very comprehensive handbook. There is little about the planning, execution, and validation of automated processes that is lacking from this book, and I would think that it would become the little red book carried by every worker seeking entry into this area.

    "-Pharmaceutical Development and Technology

    "…gives a splendid overview on information technology in the pharmaceutical industry….It is worth reading, or rather working with, the book.

    "- International Journal of Production Research

    Table of Contents


    Introduction, Joseph F. deSpautz

    Systems Planning for Automation

    Information Systems Planning, Colman O'Murchu

    Information Technology Planning for Electronic Batch Record Operations, Joseph F. deSpautz

    Human Factors and Information Systems, James L. Vesper

    Instrumentation and Process Control System Strategy, David J. Adler

    Automation Life Cycle Is More than Looking at Cost: It's a New Tool for Competitiveness, Steven B. Williams and David J. Adler

    Managing the Manufacturing Control Domain, Sean M. Megley

    Distributed Client/Server-Based Batch Control System Applied as Part of the Enterprise Solution Suite Using Technology, Baha Korkmaz

    Implementing Automation

    CIM Architecture for Validated Manufacturing Systems, Joseph F. deSpautz

    System Implementation Plan for Validated Manufacturing Systems, Joseph F. deSpautz

    Enhanced Regulatory Compliance Using Manufacturing Execution Systems, Frederick R. Bickel and Richard E. Blanchette

    Investing in Education and Training, James L. Vesper

    Documenting Education and Training, James L. Vesper

    Evaluation and Certification, James L. Vesper

    Computer Systems Validation

    GMP Regulations and Computer Validation, Teri Stokes

    Validation Concepts, Kenneth S. Kovacs and Joseph F. deSpautz

    Management's Role in Computer Validation: Policy and Procedures, Teri Stokes

    Electronic Records, Electronic Signatures, and FDA Regulation Final Rule, Teri Stokes

    Applied Computer Validation Plan for Manufacturing Execution Systems, Frederick R. Bickel and Richard E. Blanchette

    One Keyboard Pounder's Views on Validation, Joseph A. Hercamp

    A Validation Plan for Process Automation, Kenneth S. Kovacs and Joseph F. deSpautz

    Performance Qualification Testing of Integrated MRP/MES, Joseph F. deSpautz and Kenneth S. Kovacs

    Life Cycle Documentation for MRP-MES-PCS Integration, Joseph F. deSpautz and Kenneth S. Kovacs

    Supply Chain Automation

    Research and Development Automation, Jeffrey S. Gramm

    Plant Design and Engineering, Jack Conaway

    Logistics, Joseph J. Kowalski

    Bringing Distributed Control Systems into the World of Client-Server Batch Control, Anthony R. Gonzalez and Mark Castro

    Batch Process Automation, Teddy H. Tom and Kenneth S. Kovacs

    About the Series

    Drugs and the Pharmaceutical Sciences

    Learn more…

    Subject Categories

    BISAC Subject Codes/Headings:
    MEDICAL / Pharmacology