Building a good manufacturing practice (GMP) facility involves several factors such as the location of the facility, the type of the air handling system, the type of the intended product and the facility design; this post will focus on the design of the facility.

Coming up with an effective facility design is very critical; building and maintaining a GMP facility is expensive but if you spend the time upfront during the designing phase to reach an effective design, you can control the cost of the facility operation; this is critical because this cost is ongoing.

Before we go farther, let me explain what I mean by an effective design. Operating a GMP facility involves staff, material, waste, environment, products, processes, and regulations. When your facility design makes these components work cohesively, then your design is effective.

Following are few points for you to consider during the designing phase:

1. Flow

 

• Material: think of how materials will be moved in the facility; where will they be sanitized, stored, and how personnel would have access to them.
• Product (initial / samples / finished): consider how the starting product would be delivered to personnel inside the facility, and how processing samples will be delivered for testing. Also, consider how the finished product will be moved from processing to storage or distribution.
• Waste: consider how the biohazardous waste will be moved out of the processing area and out of the facility for proper disposal.
• Staff: consider how personnel will be moving inside the facility, and how will they move between specific areas of the facility. This is particularly important to prevent contamination and cross contamination of products.

2. Access

Consider utilizing an access-system to grant and monitor access to facility, and to prevent entry of unauthorized persons.

3. Differential Pressure (DP)

DP plays a critical role in preventing contamination and cross-contamination. Consider having the capacity to adjust parts of the facility to be negative pressure or vice versa depending on the process nature and the associated potential risk.

4. Monitoring

Consider utilizing a monitoring system to monitor the facility temperature, humidity, pressure, alarm status, etc. Such systems are very useful in providing a detailed picture of how the facility is performing, they are also helpful in tracking events and in preventing unnecessary alarms by adjusting the facility status. Built-in systems that are installed during construction phase can also provide an automated unattended sampling capability of the facility environment at the designated times.

5. Production

Consider all materials that will be used in production including gases. Some processes involve gas addition to the production system, such as the bioreactor. Consider installing the pipelines during the construction phase to avoid potentially disrupting the production in the future to install the pipeline.

6. Expansion

Although most programs start with limited production capacity, they usually increase their capacity gradually. Consider having this as an option for the future such as adding new product/process or scaling up of production.

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