Artículos relacionados a Validation of Pharmaceutical Processes: Sterile Products,...

Validation of Pharmaceutical Processes: Sterile Products, Second Edition - Tapa dura

 
9780824793845: Validation of Pharmaceutical Processes: Sterile Products, Second Edition
Tapa dura
ISBN 10: 0824793846 ISBN 13: 9780824793845
Editorial: CRC Press, 1998

Sinopsis

Featuring contributions from 25 specialists, this book provides a single-source reference on the design of systems, qualification of equipment, calibration and certification. It covers explicit procedures for the validation of systems required in the preparation of aseptic and nonaseptic pharmaceutical products. Topics include installation qualification, operational qualification, and change control, F, D, and Z values, steam sterilization-in-place technology and validation, sterilization methods, protocols that allow procedures to be applied directly, obstacles that may be encountered at any stage of the validation program, and suggested solutions.

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

Críticas

"easy to read and informative.an excellent blend of theoretical knowledge and applied practical considerations." -American Journal of Pharmaceutical Education "this comprehensive bookwillprove very useful to those designing a facility for producing sterile and nonsterile productsa good mix of the theoretical and applied." -Irish Pharmacy Journal "an excellent presentation on the subject of validation of pharmaceutical processes related to sterile products. It is written in a simple language and can be easily understood at the same time without losing the importance of the subject. The book will be an asset to education institutions in pharmacy and pharmaceutical technology, project and manufacturing personnel of sterile product manufacturing organisations and also to quality assurance and R&D personnel." -Pharmatimes "overwhelmingly valuable to anyone who has anything at all to do with the manufacture of sterile products, or with the processes associated with their production." - Pharmaceutical Development and Technology Promo Copy

Reseña del editor

Featuring contributions from 25 specialists, this book provides a single-source reference on the design of systems, qualification of equipment, calibration and certification. It covers explicit procedures for the validation of systems required in the preparation of aseptic and nonaseptic pharmaceutical products. Topics include installation qualification, operational qualification, and change control, F, D, and Z values, steam sterilization-in-place technology and validation, sterilization methods, protocols that allow procedures to be applied directly, obstacles that may be encountered at any stage of the validation program, and suggested solutions.

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

Editorial
CRC Press
Año de publicación
1998
Idioma
Inglés
ISBN 10 
0824793846
ISBN 13 
9780824793845
Encuadernación
Tapa dura
Número de edición
2
Número de páginas
856
Editor
Carleton Frederick J., Agalloco James P.
Contacto del fabricante
no disponible
Persona responsable
no disponible