ABSTRACT
This chapter is unlike most of the others in this book, as it requires several interlinking strands in Annex 11 and the general chapters of EU GMP to be presented and discussed. In addition, some readers may not be familiar with the concept of the cloud or the regulatory implications of cloud computing. Therefore, this chapter will be structured as follows:
◾ Regulatory requirements of Annex 11 and some of the other EU GMP general chapters
◾ A definition of cloud computing and the focus on the main types for pharmaceutical companies
◾ Requirements for IT infrastructure qualification as per the Principle of Annex 11
◾ Selection of a hosting company including the benefits of an audit ◾ Main elements of the agreement between the company and the service provider
◾ Operational and monitoring phase of the work
The requirements for GMP-compliant cloud computing are contained in several sections of EU GMP Annex 111 as shown in the following:
Principle: IT Infrastructure shall be qualified.
