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. 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.

About the Author

Graham C. Wrigley

"About this title" may belong to another edition of this title.

Store Description

Visit Seller's Storefront

Seller's business information

Edward Bowditch Ltd
Exstowe, Exton, Exeter, EX3 0PP, United Kingdom

Sale & Shipping Terms

Terms of Sale

Legal entity name: Edward Bowditch Ltd
Legal entity form: Limited company
Business correspondence address: Exstowe, Exton, Exeter, EX3 0PP
Company registration number: 04916632
VAT registration: GB834241546
Authorised representative: Mr. E. Bowditch

Shipping Terms

Orders usually dispatched within two working days. Please note that at this time all domestic United Kingdom orders are sent by trackable UPS courier, we choose not to offer a lower cost alternative.

Shipping rates from United Kingdom to U.S.A.

Shipping rates from United Kingdom to U.S.A.
Order quantity	7 to 14 business days	2 to 3 business days
First item	US$ 13.49	US$ 33.72

Delivery times are set by sellers and vary by carrier and location. Orders passing through Customs may face delays and buyers are responsible for any associated duties or fees. Sellers may contact you regarding additional charges to cover any increased costs to ship your items.