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Regulation & Policy |
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Validating Pharmaceutical Systems
Good Computer Practice in Life Science Manufacturing
Publication Date March 2005
Publisher CRC Press
Product Type Book
Pages 576
ISBN Number 084932324X
Product Code CRC096
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Summary
This publication :-
- Covers computer system validation from all perspectives: GLP, GCP, GMP, and GDP
- Concludes each chapter with summaries of do's and don'ts written by international experts working in current computerized systems validation
- Provides coverage of manufacturing execution systems and laboratory information systems
- Includes a glossary that defines all technical terms as well as an abbreviation guide
- Contains invaluable suggestions on life cycle management, electronic records and signatures, risk management, and regulatory inspections
All too often, the words "computer validation" strike terror into the hearts of those new to the process and may even cause those familiar with it to tremble. Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing delineates GCP, GLP, and GMP regulatory requirements and provides guidance from seasoned practitioners on how to fulfill them. John Andrews and his team tackle the perceived complexities surrounding the validation of a wide variety of automated systems.
Sprinkled with case studies and real-life examples, the book offers a step-by-step review of topics such as planning, design, auditing, risk management, and specification. The in-depth, by example coverage demystifies the challenges of manufacturing execution systems(MES), laboratory information management systems(LIMS), and network qualification.
The first section examines the different levels of automated systems used throughout the drug development, manufacture, and delivery lifecycle, using the GAMP 4 lifecycle approach to their validation. The second section uncovers some real-life applications of GAMP 4 to different areas of the regulations such as GLP, GCP, GMP, and GDP.
The book explores some of the latest thinking on computer validation and reflects changes that have occurred in the industry since the early days of validation. The contributors are a deliberate blend of those who have faced the problems of the 1990s and the Y2K controversies and those who have more recently arrived on the scene and made an impact on the perception of validation of automated systems across the field of GxP. They do more than show you how to do the right thing; they show you how to do the right thing in compliance with regulations.
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Content
Foreword
Editor's Introduction
Considerations for Computerized System Validation in the 21st Century Life Sciences Sector
An Inspector's Viewpoint
State of the Art Risk Assessment and Management
Validation Planning and Reporting
Audit Preparation for Suppliers: A Question and Answer Approach
Developing Good Specifications
Traceability of Requirements Throughout the Lifecycle
Good Documentation in Practice
Good Testing Practice: Part 1
Enterprise Resource Planning Services - Aligning Business and Validation Requirements
Calibration in Practice
Validating Legacy Systems
Technology Transfer Keys
Qualifying SCADA Systems in Practice Acquisition
The Application of GAMP4 Guidelines to Computer Systems Found in GLP Regulated
The Validation of a LIMS System - A Case Study
Compliance and Validation in Central and Eastern Europe (CEE)
Distribution Management Validation in Practice
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