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How to Develop and Manage Qualification Protocols for FDA Compliance - Tapa dura

Cloud, Phil

 
9781574910988: How to Develop and Manage Qualification Protocols for FDA Compliance
Tapa dura
ISBN 10: 1574910981 ISBN 13: 9781574910988
Editorial: CRC Press, 1999

Sinopsis

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.

    • "Sinopsis" puede pertenecer a otra edición de este libro.

    Acerca del autor

    Phil Cloud

    "Sobre este título" puede pertenecer a otra edición de este libro.

    Editorial
    CRC Press
    Año de publicación
    1999
    Idioma
    Inglés
    ISBN 10 
    1574910981
    ISBN 13 
    9781574910988
    Encuadernación
    Tapa dura
    Número de edición
    1
    Número de páginas
    386
    Contacto del fabricante
    Taylor and Francis, GPSR Taylor and Francis
    gpsr@taylorandfrancis.com

    Taylor & Francis Verlag GmbH, Kaufingerstraße 24
    München
    80331
    Alemania