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Validation of Pharmaceutical Processes - Tapa dura

 
9780849370557: Validation of Pharmaceutical Processes
Tapa dura
ISBN 10: 0849370558 ISBN 13: 9780849370557
Editorial: CRC Press, 2007

Sinopsis

Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine validation and six sigma system design; the preparation of aseptic and non-aseptic pharmaceutical products; active pharmaceutical ingredient and biotechnology processes, computerized systems; qualification and cleaning of equipment; analytical methods, calibration and certification. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded is a comprehensive analysis of all of the fundamental elements of this arena with practical solutions for every pharmaceutical and bio-pharmaceutical production process.

Presenting theoretical knowledge and applied practical considerations, this title

  • provides an in-depth discussion of recent advances in sterilization
  • identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions
  • explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results
  • blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions

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

    Acerca del autor

    James P. Agalloco, Frederick J. Carleton

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

    Editorial
    CRC Press
    Año de publicación
    2007
    Idioma
    Inglés
    ISBN 10 
    0849370558
    ISBN 13 
    9780849370557
    Encuadernación
    Tapa dura
    Número de edición
    3
    Número de páginas
    756
    Editor
    Agalloco James P., Carleton Frederick J.
    Contacto del fabricante
    no disponible
    Persona responsable
    no disponible