Setting Up Your Dietary Supplement Manufacturing Site

Select and build-out your Dietary Supplement or Nutraceutical manufacturing facility correctly, so that you don’t waste time and money with a facility that doesn’t meet compliance or certification requirements.

Key dietary supplement facility-related requirements that you should keep in mind when getting started include: Clean room requirements and Gown / De-gown Room or PPE Transition Zone

In addition to the facility requirements that are specific to dietary supplements, the cGMP general facility requirements are also shared below.

Dietary Supplement Clean Room Requirements

Dietary supplement and Nutraceutical manufacturing and processing cleanrooms must meet the requirements of FDA’s cGMP requirements listed in 21 CFR Part 111, which describe how companies must have easily cleanable facilities, to include adequate air filtration, climate control, dust control, and easily cleanable surfaces.

Air Filtration- Dietary supplement facilities should utilize high-efficiency particulate air (HEPA) filters to limit dust and other contaminants.
Climate control- Dietary supplements require controlled temperature and humidity in order to prevent microbial growth, potency loss, and clumping.
Controlled air pressure- Clean rooms should utilize controlled air pressure to prevent unfiltered air going into clean zones. Dietary supplement manufacturing facilities are typically designed with the air pressure inside the cleanroom to be higher than the pressure in neighboring areas or hallways, forcing air to push outward whenever doors open, stopping dust and germs from entering.
Epoxy Flooring- Epoxy flooring is important for dietary supplement manufacturing because it provides a non-porous surface that allows for easy clean-up and it minimizes dust, dirt, and bacteria.
Easy-to-clean Walls- Walls in a dietary supplement manufacturing or processing location should be non-porous, smooth, and durable.

Gown / De-gown Room or PPE Transition Zone

Personal protective equipment (PPE) transition zones are an area where workers put on or take off protective garments, face masks and hair nets. It is important to have these transition zones, so the PPE is not contaminated from other areas of the facility.

cGMP Facility Requirements to Address Prior to Audit

In addition to Dietary Supplement and Nutraceutical manufacturing building requirements, review our blog post on “Food Facility Checks To Do Before Your Food Safety Audit”. This blog post highlights additional facility considerations and fixes that should be made before audit including: door gap checks, keeping doors closed, warm water at hand sinks, fixing temporary repairs on facilities or equipment, eliminating condensation & ice build up, allergen storage & segregation, restroom construction and design, trash cans and waste can labeling, avoiding exposed wood, secure chemical storage, and backflow preventer testing

Dietary Supplement Manufacturing Training Videos and Downloads

View our Dietary Supplement Manufacturing Free Video Series & Related Free Resources for the following:

Episode 1: Introduction to Dietary Supplements

Episode 2: Regulatory Framework of Dietary Supplements

Episode 3: Best Practices for Dietary Supplement Operations

Episode 4: Testing in a Dietary Supplement Program

Episode 5: GMPs in a Dietary Supplement Program

Episode 6: Dietary Supplement Certification

If you would like help writing and implementing a dietary supplement certification or compliance program contact us for a free consultation.

(800) 535-1376 info@kellermanconsulting.com

Setting Up Your Dietary Supplement Manufacturing Site