Facility Validation: Theory, Practice, and Tools Graham C. Wrigley

ISBN: 9781280536878

Published: March 24th 2009

ebook

140 pages


Description

Facility Validation: Theory, Practice, and Tools  by  Graham C. Wrigley

Facility Validation: Theory, Practice, and Tools by Graham C. Wrigley
March 24th 2009 | ebook | PDF, EPUB, FB2, DjVu, audiobook, mp3, ZIP | 140 pages | ISBN: 9781280536878 | 6.71 Mb

Often considered a necessary evil by the pharmaceutical industry, validation is still understood by many as unrestrained bureaucracy, paperwork, and procedures whose roots and logic are obscure and only serve to slow down progress. ThoroughlyMoreOften considered a necessary evil by the pharmaceutical industry, validation is still understood by many as unrestrained bureaucracy, paperwork, and procedures whose roots and logic are obscure and only serve to slow down progress.

Thoroughly defining the philosophy, application, and processes, Facility Validation: Theory, Practice, and Tools explores the validation issues relevant to the start-up of a new or upgraded manufacturing facility.The author describes policies, guidelines, and regulations relating to GMPs in the pharmaceutical industry and explores the relationship between these GMPs and the validation process. He outlines the theory and clarifies the philosophy and key principles of validation such as life-cycle approach and qualification practices. The book includes coverage of common pitfalls and how to avoid them, the difficulties and constraints a validation team has to manage, and the dangers of not adopting and following the recommended best practices.

Facility validation has, in fact, become good business. It can be a tool for enhancing reliability, cost, and quality.- This book makes the case that design, engineering, commissioning, and validation activities can be integrated and streamlined to accelerate a pharmaceutical manufacturing plant start-up effort, and demonstrates how to use best practices to achieve the results you desire in your organization.



Enter the sum





Related Archive Books



Related Books


Comments

Comments for "Facility Validation: Theory, Practice, and Tools":


zsgozd.pl

©2014-2015 | DMCA | Contact us