Validation Fundamentals
Validation is the most complex and costly activity of all the requirements imposed by GMPs. Validation must be performed to assure patient safety, and it must be performed effectively to pass regulatory inspection. This book details the basis of the process. Follow the step-by-step directions, and you will save time, money, and frustrations -- and you will meet all regulatory expectations.
Written by the founders of the Institute of Validation, this practical introduction to the topic of validation cuts through all the jargon and focuses on the essential issues. Beginning with definitions of validation, the authors deftly guide you through all the basics, associated costs, responsibilities, policies, strategies, support activities, SOPs, Master Plans, and all other relevant efforts and consequences.
Packed with proven tools designed to help you recognize and retain the logic of the process, this remarkable book covers testing, certification, protocols, final reports, sign-offs, ways to create seamless audit trails, and all other topics impacting the qualification of a critical system, equipment, and/or process. Fourteen themes in critical-path sequence include:
- What is Validation?
- The History and Roots of Validation
- Why Do We Validate and How Much Does It Cost?
- Who Is Responsible for Validation?
- How Does Validation Affect You?
- Validation Policy, Strategy Protocols, and the Validation Report
- What Activities Support the Validation Effort?
- What Are the Consequences of Not Validating?
- For Whom Are We Validating?
- Preparing Standard Operating Procedures and the Validation Master Plan
- How Do We Plan and Programme Validation?
- Glossary of Validation Terminology
- cGMP and Standards Related to Training and Education
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