Since the FDA and EMS have actively begun sponsoring the Quality by Design (QbD), this has started to be a more and more active philosophy in the development of new drugs. Pharmaceutical companies have grasped the real value and the benefits that this new approach can produce and have started to introduce it in the projects they deem as the most important. In order for the QbD to be successfully implemented, it is necessary to develop an in-depth and consolidated knowledge of the involved processes, from the production of the active ingredient to the production of the finished pharmaceutical form. A single company, however big, can’t manage all the project’s stages and needs to outsource a part of it. Thus it becomes critical, in order to implement the QbD, that a clear and direct communication channel is opened between the customer and the service supplier, so that the latter can help the former in the elaboration of the QbD connected to the supplied service.

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Design space of the micronizationprocessbased on the Quality by Design (QbD)

corresponding

ALESSANDRO QUAGLIA
JETPHARMA SA
Via Sottobisio 42a/c, P.O. Box 234, CH-6828 Balerna, Switzerland

Abstract

Since the FDA and EMS have actively begun sponsoring the Quality by Design (QbD), this has started to be a more and more active philosophy in the development of new drugs. Pharmaceutical companies have grasped the real value and the benefits that this new approach can produce and have started to introduce it in the projects they deem as the most important. In order for the QbD to be successfully implemented, it is necessary to develop an in-depth and consolidated knowledge of the involved processes, from the production of the active ingredient to the production of the finished pharmaceutical form. A single company, however big, can’t manage all the project’s stages and needs to outsource a part of it. Thus it becomes critical, in order to implement the QbD, that a clear and direct communication channel is opened between the customer and the service supplier, so that the latter can help the former in the elaboration of the QbD connected to the supplied service.


 

INTRODUCTION

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