Our objectives for this session are split into 4 main areas:

1. We will review in detail the general requirements that GMP make on the location and design of the premises. We will be looking at the principles supporting all aspects of the design of the factory.

2. Having done that we will have a group session in which we will be asking you to use your knowledge of the general principles and your practical experience in your country to review a concept drawing of a facility “faxed” through to your group. The plan is only on one page, A4 but this is sometimes typical of plans faxed through for comment.

3. We will then examine each key area and review the special requirements for building design. We will also look at the role of the premises in the prevention of cross-contamination.

4. In the second group session we want you to look at a multifunction factory and to define the GMP facilities that you would expect to find there. There is another concept drawing of a sterile facility faxed through to your group for comment.