INTEGRATION OF ICH GUIDELINES IN EXISTING MANAGEMENT SYSTEMS FOR (BIO)PHARMACEUTICAL COMPANIES

Stefan Leitgeb

Research output: ThesisMaster's Thesis (University Course)

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 contributionINTEGRATION OF ICH GUIDELINES IN EXISTING MANAGEMENT SYSTEMS FOR (BIO)PHARMACEUTICAL COMPANIES
Original languageEnglish
Supervisors/Advisors
  • Schröder, Werner, Supervisor (internal)
Award date16 Dec 2011
Publication statusPublished - 2011

Bibliographical note

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