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

Design Principles

Keep in mind:

  • Material flow

  • People flow

  • Process flow

Ensure logical flow

When designing any facility it is most important to set out the principles upon which that design will be based. It is also important to ensure that the flows of process, material and people are brought together without conflict.

It sounds easy to say but it is not so easy to do. Let us consider each design principle in turn.

Process flow: What we are looking for here is the sequence of events that will take place in a process. For those of us who are familiar with the industry, this may seem simple. However, the company may well be talking with engineers who know nothing of pharmaceutical manufacture. It means describing for the engineers the way in which the process is operated, the equipment that will be used and the services required. It also means describing the environment required by the product. All of this information can be put into a room data sheet.

Material flow: Material flow is shown on the plan of the factory as the routing of materials throughout the facility. It is important to show the status of the materials as well. This means indicating whether they are quarantined, approved or rejected, and also the volume, weight or frequency of movement, and the way in which the material is to be moved. Will it be moved by forklift truck, by pipeline or manually by people? Frequently people show all of this with different coloured lines on a factory layout with different thickness of line to show frequency of movement. In this way it is possible to identify areas of high movement frequency and where the floor is going to have to be very strong to resist the high workload that is placed on it. Materials should flow in the direction of manufacturing. There should be no cross-flow of materials. All of this information is placed on the factory layout plan.

People flow: A plan of the factory showing the routing taken by people when they enter the factory, when they move around in the factory from one department to another, and when they leave the factory. It should also show how visitors will enter and where they will go. It can show how people will move from the office areas to the warehouse. People should be limited to those areas where they have their activities. Production areas should not be used as passages or corridors for non-essential personnel movement. This is particularly important in the case of purchasing and accounts department staff who will be handling invoices for goods delivered or shipped out. This plan shows how access control is maintained.

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Dernière mise à jour: le 3 mai 2013