Premises

Abstract

This chapter outlines the general aspects of premises designed for pharmaceutical preparation activities and the steps to consider in order to achieve a justified design, construction and qualification of these premises. Also the built-in technical facilities are discussed. Premises and its technical facilities are an essential link in achieving good preparation practice. Their design and qualities should be derived from the kind of products that will be produced in it. European and WHO GMP define in general terms preconditioned criteria that have to be met by premises, including storage areas, weighing areas etc. However this chapter does not define exactly what is appropriate in any specific facility. The emphasis is on the interrelationship between the demands, the building, the installations and the provisions. The scope is general so that all small-scale production facilities for healthcare establishments and preparation centres are covered in the discussion. Also ready-made premises or modules can be assessed by comparison of their qualities with the ones mentioned in this chapter. This chapter’s arrangement follows the general approach of best practices in qualification. Important subjects covered are: •Processes that underlie the necessity to build a prepa- ration facility • Products and the legislative framework • Routing of goods and personnel and communication • Specification and classification of premises • Built-in installations for HVAC, water and gassesDetail specification and building execution • Walls, doors, floors, ceilings, heating, fixtures and fittings