How to Develop and Manage Qualification Protocols for Fda Comppliance - Couverture rigide

Cloud, Phillip A.

 
9781574910988: How to Develop and Manage Qualification Protocols for Fda Comppliance
Couverture rigide
ISBN 10 : 1574910981 ISBN 13 : 9781574910988
Editeur : CRC Press Inc, 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.

    • Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

    À propos de l?auteur

    Phil Cloud

    Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

    Éditeur
    CRC Press Inc
    Date d'édition
    1999
    Langue
    anglais
    ISBN 10 
    1574910981
    ISBN 13 
    9781574910988
    Reliure
    Relié
    Nombre de pages
    375
    Coordonnées du fabricant
    non disponible
    Personne responsable
    non disponible