Bookcover of Process Validation of Ceftriaxone Sodium Dry Injection
Booktitle:

Process Validation of Ceftriaxone Sodium Dry Injection

A Step of Pharmaceutical Industry

LAP LAMBERT Academic Publishing (2012-04-08 )

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ISBN-13:

978-3-8484-9181-0

ISBN-10:
3848491818
EAN:
9783848491810
Book language:
English
Blurb/Shorttext:
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.
Publishing house:
LAP LAMBERT Academic Publishing
Website:
https://www.lap-publishing.com/
By (author) :
Deepak Sharma, Shashank Tiwari
Number of pages:
80
Published at:
2012-04-08
Stock:
Available
Category:
Pharmacy
Price:
49.00 €
Keywords:
Validation, Process Scale up, Pharmaceutical Sciences

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