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.
Table of Contents
Foreword, Guy Wingate
Editor's Introduction, John Andrews
Considerations for Computerized System Validation in the 21st Century Life Sciences Sector, T. De Claire, P. Coady, and N. Stevens
An Inspector's Viewpoint, S. Clark
State of the Art Risk Assessment and Management, J. Andrews
Validation Planning and Reporting, C. Clark
Audit Preparation for Suppliers: A Question and Answer Approach, G. Wingate
Developing Good Specifications, M. Cherry
Traceability of Requirements Throughout the Lifecycle, K. Collyer and J. Dick
Good Documentation in Practice, M.L. Wyrick
Good Testing Practice: Part 1, D. Stokes
Enterprise Resource Planning Services - Aligning Business and Validation Requirements, A. Nobibux, J.C Peters, S. Sharp, and J.E.H. Stafford
Calibration in Practice, M.E. Foss
Validating Legacy Systems, S. Schmitt
Technology Transfer Keys, S. Green and P. Warren
Qualifying SCADA Systems in Practice Acquisition, O. Lopez
The Application of GAMP4 Guidelines to Computer Systems Found in GLP Regulated, P. Coombes
The Validation of a LIMS System - A Case Study, D. Hogg and F. Pedeconi
Compliance and Validation in Central and
Eastern Europe (CEE), P. Irving, C. Turner, W. Duncan, and D. Forrest
Distribution Management Validation in Practice, B. Gilkes