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Key considerations include location, building materials, layout, and process flow.
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:
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:
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.
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:
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.