What Is The Process to Manufacturing Dietary Supplements?

Where 77% of Americans take at least one dietary supplement, dietary supplements are a growing profitable industry. But to produce high-quality dietary supplements, nutraceutical companies must adhere to rigorous production regulations and testing to ensure potent and safe products.

Ever wondered about the process of manufacturing dietary supplements? We break down the step-by-step process of how dietary supplements are made.

Step-by-Step Process for Manufacturing Dietary Supplements

Manufacturing dietary supplements is a rigorous process of development, production, and quality assurance to ensure high-quality nutritional supplements. Here are the steps that go into the production process.

1. Develop The Formula

After researching and experimenting, a team of nutritional scientists and dieticians formulate a supplement that has:

• The correct dose of each raw material ingredient
• Documentation and proof of efficacy and can substantiate the supplement’s structural and functional claims

This step can vary in time as the team explores and validates each raw material ingredient’s benefits.

2. Select Raw Materials

Once raw materials are identified, the development team selects the best evidence-based raw materials from around the world. These ingredients may have:

• High potency
• Bioavailability
• Excellent absorption
• Strong bonding quality
• Guaranteed amount of natural active or marker compounds

This step can take as little as a week or take years, depending on the raw materials needed.

Related Link: GMP Consulting

3. Price the Formulation

The brand manager for the supplement submits a price quote request to the dietary supplement manufacturer. Based on the formula and the required raw ingredients, the manufacturer will determine the dietary supplement’s price after sourcing all ingredients.

Within five to ten days, the brand manager will receive the price quote from the manufacturer for the new dietary supplement.

4. Submit Purchase Order

Once the brand manager receives the price quote, they can assess if the price is too high for market demands. If the price is too high, they may have the development team reformulate the supplement to be less cost-prohibitive.

If the price quote is in line with market demand, the brand manager will submit a Purchase Order to the manufacturer. This can be done the same day as receiving the price quote but mostly depends on the brand manager’s approval process.

5. Order Raw Materials

The manufacturer orders the raw materials from its different sources. Depending on how exotic, scarce, stable, or challenging to obtain the ingredients, it may take a while to receive the raw materials. Some ingredients, like probiotics, have to be grown. This can be the longest step in the process of manufacturing dietary supplements.

Sometimes the manufacturer may have the raw materials stocked but depending on how big the order is, they may need to order more. This step can take from two to eight weeks, depending on the ingredients.

6. Receive, Quarantine, and Test Raw Materials

Once the raw materials arrive, the manufacturer must follow Current Good Manufacturing Practice (CGMP) regulations set by the FDA before inventorying the materials. The CGMP regulations require that the raw materials undergo quarantine and testing to meet FDA standards.

For dietary supplements, many raw materials must pass the following tests:

• Identity and Potency Test: Raw materials must be tested for potency against a validated sample of the raw material.
• Microbiological Test: Raw materials must be tested for microbiological compliance and don’t contain dangerous microorganisms like E Coli.
• Heavy Metal Test: Raw materials must be tested for lead, cadmium, arsenic, and mercury to ensure the material is safe to ingest. Failure to pass these tests can result in hefty fines from some states.

This step can take one to two weeks. Once the raw materials are approved for inventory, the manufacturer can start production.

Do you need a third party for dietary supplement testing? Contact Hanbit to learn more about their quality lab testing for dietary supplements.

Related Link: Lab Testing and Quality Control

7. Complete Bench Work

The manufacturer produces a limited sample of the supplement for the brand manager and the research and development team to evaluate. This first sample is called an R&D batch, where the raw materials are mixed and made into tablets or capsules.

This step can take up to a week. Once the brand manager approves the sample, the dietary supplement can move to the production pilot batch.

8. Produce Pilot Batch

Leveraging how they made the dietary supplement during bench work, the manufacturer then runs a pilot batch preparatory for full production. The pilot batch determines if the supplement will run correctly and to identify any problems with the formulation.

Producing an approved pilot batch can take up to a week. Once the brand manager approves the pilot batch, full production can start.

9. Start Production Run and Quality Testing

During this production stage, the finished product is made for retail distribution. Once the production is finished, a sample of the finished products must undergo more quality assurance testing. These tests include:

• Mix Uniformity Testing: Because the manufacturer mixes the raw materials on a large scale, this test guarantees that each supplement has an even distribution and uniform mixture.
• Content Uniformity Testing: Once the mix is approved, the supplements must be weighed for correct nutrient potency. While capsules are filled, a random sample is weighed for content uniformity.
• Dissolution Testing: A sample of the dietary supplement is placed in water and moved around in a small container to determine if the capsule will dissolve within 45 minutes. If it passes, then it is ready for human consumption and absorption.
• Stability Testing: Stability testing determines the shelf life and potency life of the supplement.

This step can take one to three weeks, depending on the production quantity.

10. Complete Final Testing

Once production is complete, the supplements must receive a certificate of analysis (COA) by being retested for potency, microbiological, and heavy metal compliance. The COA is sent to the brand manager for approval. Upon approval, the dietary supplement is ready for distribution.

High-Quality Dietary Supplements Requires a Strict Manufacturing Process and Testing

Dietary supplements must adhere to strict regulations and testing to guarantee safety, potency, and effectiveness. The manufacturing process for dietary supplements can take up to three to six months for production after the Purchase Order is received, depending on the raw materials.

Hanbit is a full-service manufacturer of dietary supplements. Hanbit services include consulting, supplement production, inventory warehousing and shipping, lab testing, and quality control. Hanbit specializes in capsule, tablet, liquid, soft gel, and gummy dietary supplement production.

Are you a dietary supplement company in need of a better manufacturer? Contact Hanbit to learn more about our competitive rates and process.

Related Link: Hanbit Contract Manufacturing