Abstract
This work describes an approach for the implementation of ICH guidelines Q8 to Q11 in a generic management system for pharmaceutical companies. Special emphasis is given to emerging topics that are introduced in these guidelines like Quality by Design. It is described how the approaches can be employed and succesfully implemented in the organisation.
Translated title of the contribution | INTEGRATION OF ICH GUIDELINES IN EXISTING MANAGEMENT SYSTEMS FOR (BIO)PHARMACEUTICAL COMPANIES |
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Original language | English |
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Award date | 16 Dec 2011 |
Publication status | Published - 2011 |