Articoli correlati a How to Develop and Manage Qualification Protocols for...

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

Cloud, Phil

 
9781574910988: How to Develop and Manage Qualification Protocols for FDA Compliance
Rilegato
ISBN 10: 1574910981 ISBN 13: 9781574910988
Casa editrice: CRC Press, 1999

Sinossi

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.

    • Le informazioni nella sezione "Riassunto" possono far riferimento a edizioni diverse di questo titolo.

    Informazioni sull'autore

    Phil Cloud

    Le informazioni nella sezione "Su questo libro" possono far riferimento a edizioni diverse di questo titolo.

    Editore
    CRC Press
    Data di pubblicazione
    1999
    Lingua
    Inglese
    ISBN 10 
    1574910981
    ISBN 13 
    9781574910988
    Rilegatura
    Copertina rigida
    Numero edizione
    1
    Numero di pagine
    386
    Contatto del produttore
    Taylor and Francis, GPSR Taylor and Francis
    gpsr@taylorandfrancis.com

    Taylor & Francis Verlag GmbH, Kaufingerstraße 24
    München
    80331
    Germania