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. 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.