WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 09): Premises
(2006; 45 pages)
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Premises

Location

  • Geography, climate, noise and economic factors

  • Neighbours

    - What do they do?

    - What impact can they have on the business?

  • Pollution/effluent control

  • Minimum risk for contamination of products and materials

The geography of the chosen location can have a considerable impact upon the design of facilities. Is the location subject to earthquake hazards? Does it experience flooding regularly - during the monsoon season for example? What precautions need to be taken regarding continuity of supply of services?

The climate of the area is also important. If the company will be handling, for example, gelatin capsules then humidity is of great concern. If the company has a lot of goods requiring temperature or humidity controls in transport, and the goods have to sit on the dockside for weeks waiting for a boat to arrive, there may be a problem with the quality of the products. The company may need to rent temperature-controlled storage. If it does, how will it check the quality of that storage?

The factory may have to seek some expensive design solutions to overcome the problems that arise. Does the process make a lot of noise, for example? If it does and the location is close to neighbours, then the company may be forced into expensive soundproofing.

The neighbourhood is also important. If the company is to be located next to a steel mill then the design precautions that it will have to take, and the level of maintenance that it will have to undertake, will be very different than if it is in a rural setting. If the neighbours change, the company will need to take appropriate measures to handle the situation correctly.

The company is also required to take measures that prevent the factory polluting the surrounding area with product or by-products from its manufacturing processes.

A site inspection is useful before building commences to ensure that the area is suitable for the construction of a pharmaceutical factory (See photo)

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Dernière mise à jour: le 3 mai 2013