There are three main objectives of this session:

Firstly we will review, both in terms of education and previous experience, the qualities of an inspector of pharmaceutical manufacture appointed by the national regulatory authority.

Secondly, we will look at the different types of roles that an inspector can adopt during an inspection.

Thirdly, we will talk about communications (since an inspector should be a good communicator) and the types of behaviour which is preferable for an inspector to assume during an inspection.

In 1999, the WHO adopted a guideline for GMP inspectorates called “WHO Quality Systems Requirements for National Good Manufacturing Practices Inspectorates”. Some of the issues discussed in this module are addressed in this guideline.

(The trainer should be aware of local regulations.)