How to Develop and Manage Qualification Protocols for FDA Compliance - Hardcover

Cloud, Phil

Hardcover

ISBN 10: 1574910981 ISBN 13: 9781574910988

Publisher: CRC Press, 1999

Synopsis

All current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and ISO 9000 standards and regulations require that validation document be established and followed. Yet these regulations do not provide guidelines on how to produce documentation such as qualification protocols.

How to Develop and Manage Qualification Protocols for FDA Compliance focuses specifically on the FDA documentation requirements, providing concrete guidance on how to develop and manage qualification protocols and their associated documentation to ensure your company is not at risk.

Key function areas, such as cleaning, facilities and utilities, equipment, computers and software, and process are discussed in detail. The book contains 35 validation procedures and 30 forms that can be used to establish a validation documentation system and provides protocol templates you can use as your own. Numerous diagrams and graphics are used to illustrate key points.

Most importantly, this book will provides hands-on, "been there" advice on how to:

Write protocols and final reports

Develop protocol formats and style guides

Establish a documentation review and approval system

Implement document control and forms control programs

Migrate your documentation system from paper to electronic format

If your responsibilities include writing and managing qualification protocols for drug products and related industries, here's all you need to build a cost-effective, manageable--and compliant--system.

Edition details

• Publisher: CRC Press
• Publication date: 1999
• ISBN 10: 1574910981
• ISBN 13: 9781574910988
• Binding: Hardcover
• Language: English
• Edition number: 1
• Number of pages: 386