The planning of pharmaceutical production usually includes the following services:
– collection and processing of available basic information about the facility, various approvals, technical conditions and their verification;
– help in selecting and equipping basic and auxiliary technological equipment;
– calculation of energy resources, pressurized air, water consumption;
– registration of plans of premises, including a technical floor, laboratories, warehouses of raw materials and finished goods, auxiliary spaces;
– installation of fire protection locks, sewer drains, trays and gangways and other engineering systems;
– assistance in drafting an explanatory note;
Work begins with the development of an optimal conceptual project. On its basis, it can be concluded whether the chosen site is suitable for new construction, whether there are any necessary technical facilities for the projected production at the site. But all these calculations can not be performed without a precise understanding of what technology should be used and what equipment should be selected, including the auxiliary one (for the preparation of water and air).
The explanatory note describes all the technological processes, as well as all the procedures for training personnel, premises, equipment and interventions designed to prevent cross contamination. The scope of the note should be sufficient to assess the compliance of the adopted design decisions with GMP requirements. The conceptual project must undergo an examination. This procedure is called the qualification of the DQ (design qualification) project. Elimination of the possibility of cross contamination in the production of drugs is one of the most important tasks in the planning of pharmaceutical enterprises.