How to Develop and Manage Qualification Protocols for FDA Compliance

1st Edition

Phil Cloud

CRC Press
Published August 31, 1999
Reference - 375 Pages
ISBN 9781574910988 - CAT# PH0981

For Instructors Request Inspection Copy

USD$195.00

Add to Wish List
FREE Standard Shipping!

Summary

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.
  • Instructors

    We provide complimentary e-inspection copies of primary textbooks to instructors considering our books for course adoption.

    Request an
    e-inspection copy

    Share this Title