Process Validation of Ceftriaxone Sodium Dry Injection: A Step of Pharmaceutical Industry - Couverture souple

Sharma, Deepak; Tiwari, Shashank

Couverture souple

ISBN 10 : 3848491818 ISBN 13 : 9783848491810

Editeur : LAP LAMBERT Academic Publishing, 2012

Synopsis

Validation is defined as the establishing of documented evidence which provides a high degree of assurance that a planned process will consistently perform according to the intended specified outcomes. Validation studies are performed for analytical tests, equipment, facility systems such as air, water, steam, and for processes such as the manufacturing processes, cleaning, sterilization, sterile filling, lyophilization, etc. There will be a separate validation for the lyophilizer as an equipment item and for the lyophilization process; for the cleaning of glassware and the cleaning of the facility; and for the sterilization process and for the sterility test. Every step of the process of manufacture of a drug product must be shown to perform as intended. Validation studies verify the system under test under the extremes expected during the process to prove that the system remains in control. Once the system or process has been validated, it is expected that it remains in control, provided no changes are made. In the event that modifications are made, or problems occur, or equipment is replaced or relocated, revalidation is performed.

A propos du livre

Biographie de l'auteur

The Author is emerging young author in globally. In his young age he has achieved a lot of recognitions. He is an editorial member of IJHEPS International Journal and Joint Zonal Secretary of Association for innovation, India. Total of 6 Papers and 2 Books are published in various international Journals and Publications

Détails de l'édition

• Éditeur: LAP LAMBERT Academic Publishing
• Date d'édition: 2012
• Langue: anglais
• ISBN 10: 3848491818
• ISBN 13: 9783848491810
• Reliure: Broché
• Nombre de pages: 80
• Coordonnées du fabricant: non disponible
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