Why Good Facility Design Is Crucial for GMP Compliance

Using Good Manufacturing Practices (GMPs) when designing your dietary supplement manufacturing facility is the first step towards GMP compliance. The design must actively avoid risks of contamination, permit effective cleaning, and minimize dust buildup. Potential for cross-contamination of your products must be considered. Sources of contamination that often get overlooked include:

• Air supply

• Vents

• Ledges

• Drains

Accidental contamination during any phase of manufacturing due to poor facility design can severely affect the quality of your product, resulting in poor quality, illness, consumer complaints, and FDA warning letters.

Location, Location, Location

The geographical location is an important consideration. The location most convenient for you and your staff might not result in best-quality supplements for your customers. Factors to consider include:

• Environment– Is the area subject to flooding or other hazards?

• Supply– Could there be any disruptions in obtaining proper supplies on a continuous basis?

• Neighbors– Who is next door, and could their process somehow disrupt the quality of your products, or vice versa?

• Weather – Though maintaining indoor temperature should be easy enough, if the location is known for extreme weather or potential flooding, this should be taken into account.

Building Materials

All building materials should be easy to clean and be unobtrusive to a quality environment. Walls, floors, and ceilings should be smooth for easy cleaning. No popcorn ceilings or textured walls! If you are moving your operations into an older facility, be sure to test it for contaminants such as asbestos or lead pipes. Interior temperature, humidity, and utilities should also be taken into consideration. Be sure that proper ventilation, filters, air locks, and air-conditioning systems can be installed appropriately. A constant electrical supply is also needed, so be sure it is possible to have a backup generator on site in the case of an outage.

Layout

In Figure 1.1 above (click to enlarge image), you’ll find an example of an ideal layout. Separate areas should designated for all major functions including:

• Shipping and receiving– These areas are typically close together and likely occupy the largest space near the front or rear of the facility. Due to the activity in the shipping and receiving area, this area is particularly vulnerable to contaminants from the outdoors, including insects and rodents. Incoming containers must be cleaned before entering the facility.

• Storage areas– There should be enough room in storage areas to facilitate cleaning. Segregated areas are recommended for quarantined items, finished products, bulk materials, and recalled or rejected products.

• Weighing – This area can be especially vulnerable to cross-contamination, particularly when working with powders. Environmental controls such as dust-extraction systems should be put into place to decrease the risks.

• Production – There should be separated areas where personnel and visitors change clothes before entering certain areas of the facility. The layout of the production should follow the process flow for optimal quality.

Flow

Before designing your manufacturing facility, think carefully about the flow of your process. Think about the status of the materials at each stage. What events pose a risk of contamination to the product? For example, finished products should be kept away from milling operations, and a stringent cleaning process should be put into place for equipment that is used in the creation of multiple products with different ingredients.

When considering your process, also think about the personnel involved. In figure 1.1, the arrows indicate the entrance and egress of the staff as they move through the facility. Washrooms and changing areas should be conveniently located for all staff that comes into contact with the supplements at any stage in the manufacturing process.

Building your facility with GMPs in mind will contribute to the overall quality of your products and ultimately make compliance easy. Whether you are building a new facility or choosing a new location, keeping your process flow in mind, along with following Good Manufacturing Practices, will be the keys to success.

Richard Soltero, PhD, is the president of InstantGMP Inc. (Cary, NC; www.instantgmp.com), the only cloud-based manufacturing execution system with built-in GMP workflows specific to the dietary supplement industry.

Infographic courtesy of InstantGMP Inc.