Validation of Pharmaceutical Processes - Rilegato

 
9780849370557: Validation of Pharmaceutical Processes
Rilegato
ISBN 10: 0849370558 ISBN 13: 9780849370557
Casa editrice: CRC Press, 2007

Sinossi

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

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

    Informazioni sull?autore

    James P. Agalloco, Frederick J. Carleton

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

    Editore
    CRC Press
    Data di pubblicazione
    2007
    Lingua
    Inglese
    ISBN 10 
    0849370558
    ISBN 13 
    9780849370557
    Rilegatura
    Copertina rigida
    Numero edizione
    3
    Numero di pagine
    756
    Redattore
    Agalloco James P., Carleton Frederick J.
    Contatto del produttore
    non disponibile
    Persona responsabile
    non disponibile