Facility Validation: Theory, Practice, and Tools

ISBN-13: 9780849323409 / Angielski / Twarda / 2004 / 160 str.

Graham C. Wrigley; Wrigley C. Wrigley

Opis

Focusing on validation issues specific to the start-up of a new or upgraded manufacturing facility, this book provide definitions of the policies, guidelines, and regulations relating to Good Manufacturing Practices (GMPs) in pharmaceutical industries worldwide. The author discusses the validation concepts, definitions, and terminology associated with GMPs and details the philosophy and key principles of validation. He demonstrates how to set up an infrastructure for implementing a validation program. Included in the book are practical examples of validation documents and SOPs, a comprehensive glossary of validation terminology, and best practices for evaluating validation programs.

Spis treści

ForewordIntroductionTHE REGULATORY REQUIREMENTS FOR VALIDATION IN THE PHARMACEUTICAL INDUSTRYThe Regulatory Requirements of Good Manufacturing Practices (GMP's)The Relationship between Validation and the GMP'sThe Impact of Changing Regulations on the Scope and Extent of ValidationThe Future for the GMP'sTHE FUNDAMENTALS AND ESSENTIALS OF VALIDATIONValidation Concepts, Definitions and TerminologyThe Philosophy and Key Principles of ValidationOrganizing and Planning for ValidationThe Essential Validation DisciplinesTHE PRACTICE OF FACILITY VALIDATIONA Typical Life Cycle Approach for the Qualification and Validation of a Pharmaceutical Manufacturing FacilityTWENTY TOOLS RECOMMENDED FOR FACILITY VALIDATIONCommon Problems associated with Facility ValidationGood Validation PracticesGOOD VALIDATION PRACTICESThe Benefits of Following Good Validation Practices in Facility Validation ProjectsThe Consequences of Not Following these Good Validation PracticesCONCLUSIONS AND FUTURE DIRECTIONS

O autorze

Graham C. Wrigley