The fifth National Pharmaceutical Sciences Conference
22-24 April 2005 , Benghazi-Libya
Pharmaceutical Validation
Dr. Omelkheir Brngali
QA Department-Almaya Pharmaceutical Factory
ABSTRACT
What is Validation? There types, objectives, elements, principles and rules. Why to do Validation? And How? All criteria regarding validation will be aspected throughout this paper which cover Validation elements including:
· Design qualification
· Risk analysis
· Installation qualification
· Operational qualification
· Performance qualification
· Process validation
· Cleaning validation
· Computer validation
In additional, this paper says how to Write and execute cGMP validation documents as carried out at Almaya Pharmaceutical Factory. |
