Validation of Pharmaceutical Processes

Authored by: James Agalloco

Encyclopedia of Pharmaceutical Science and Technology

Print publication date:  July  2013
Online publication date:  July  2013

Print ISBN: 9781841848198
eBook ISBN: 9781351124874
Adobe ISBN:


 Download Chapter



Validation is a required activity worldwide for confirmation of process and system acceptability. It goes well beyond inprocess and finished goods testing using independent assessments of process parameters and targeted sampling to establish definitive proof of process suitability. The activity called ‘Validation’ in the global healthcare community is based upon the classic scientific method: establishment of a premise; design of an objective means for confirming the premise; conduct of experimentation with collection of data; and preparation of a report confirming the premise.

Search for more...
Back to top

Use of cookies on this website

We are using cookies to provide statistics that help us give you the best experience of our site. You can find out more in our Privacy Policy. By continuing to use the site you are agreeing to our use of cookies.