Step-by-Step Process of Manufacturing Dietary Supplements

Welcome to The Supplement Insider - our brand-new LinkedIn newsletter.?

Here we explore some of the most buzzworthy nutraceutical topics and gather insights from experts on dietary supplements.?

Today’s topic explores the step-by-step process of manufacturing dietary supplements and the read time for this edition is 5 minutes.

A note about the author: Gene Bruno, MS, MHS, RH(AHG) possesses over 44 years of dietary supplement industry experience. With a Master's degree in nutrition and a second Master's degree in herbal medicine, he has a proven track record of formulating innovative, evidence-based dietary supplements. Mr. Bruno currently serves as both the Vice President of Scientific & Regulatory Affairs at NutraScience Labs and Professor of Nutraceutical Science at Huntington University of Health Sciences.

How long does it take to manufacture dietary supplements?

The timeframe for completing the supplement manufacturing process varies on the product you want to create and the amount of customization required. On average, though, it typically takes 12 to 16 weeks from the date a purchase order (P.O.) is received.?

What I share with you next is extremely important - especially if you are new to the industry.

Any supplement manufacturer that promises you a shockingly fast turnaround time (e.g., 4 weeks) is either lying to earn your business or cutting corners during the manufacturing process to create your product. Proceeding with an untrustworthy vendor could harm your customers and the reputation of your business. Therefore, understanding this process and the amount of work involved is of the utmost importance.

Over the next few paragraphs, I will provide a start-to-finish overview of the dietary supplement manufacturing process and answer the most common questions about manufacturing supplements.

Scroll to continue reading or click below to listen to the podcast I recorded about this topic here: https://www.podbean.com/ep/pb-23ri9-12f9f0d?

I'll begin by explaining the step-by-step process of manufacturing a high-quality supplement from scratch:

• Step 1: The Formula
• Step 2: Selection of Raw Materials
• Step 3: Pricing Out the Formulation
• Step 4: Purchase Order Submission
• Step 5: Ordering Raw Materials
• Step 6: Raw Materials Arrive & Are Quarantined and Tested
• Step 7: Bench Work
• Step 8: Pilot Batch
• Step 9: Production Run and Testing
• Step 10: Testing of Finished Products

Step 1: The Formula

It all starts with the formula. Hopefully, as a brand owner, you’ve made sure that your dietary supplement formula uses the correct doses of the right raw material ingredients to provide an evidence-based product that will have efficacy, and that will allow you to substantiate structure/functions claims. Although a well-formulated dietary supplement will not guarantee initial sales, it does make it much more likely that you’ll have consistent repeat sales once consumers have used it for the first time.

Step 2: Selection of Raw Materials

A well-formulated dietary supplement requires the use of evidence-based ingredients to help assure product efficacy. Ingredients may be selected worldwide on the basis of quality, and eying forms that provide high potency and bioavailability. For example, many mineral supplements include well-absorbed mineral salts bonded to organic acids, including citrates, picolinates, and gluconates. Likewise, formulas with herbal extracts may include standardized extracts with guaranteed amounts of the natural active or marker compound within the herbs.

Step 3: Pricing Out the Formulation

The first step begins when a brand owner submits a request for pricing to the contract manufacturer (CM). In turn, the CM will create their own version of the formulation and verify raw material pricing for key ingredients with various vendors. Once all of this is done, the CM will provide a price quote to the brand owner.

Timeline: The CM’s process of developing their own version of formulation and verifying raw material pricing will typically take anywhere from 5-10 days.

Step 4: Purchase Order Submission

The real countdown begins once the brand owner submits the purchase order. Now that they know there is a commitment, the CM can go to town and really get the supplement manufacturing process going.

Step 5: Ordering Raw Materials

Without question, this is the step that takes the longest in the manufacturing process. Why? Here’s an example.

Let’s say that the raw material in question is a probiotic. As live microorganisms, probiotic ingredients are typically made to order. They literally must be grown on a natural medium, and that doesn’t happen overnight. In fact, growing probiotics may take 6 weeks or so. Now let’s say those probiotics come from Italy (which is often the case), so that means the finished material will be shipped internationally - which will take 1-2 weeks.

Of course, there are many raw materials other than probiotics - some of which have better stability and may even be stocked by the CM. Nevertheless, chances are that your chosen raw materials may not be stocked by the CM, or may not be stocked in sufficient quantities, so more will still have to be ordered. This will take 2-4 weeks to arrive.

Step 6: Raw Materials Arrive & Are Quarantined and Tested

Once the raw materials arrive at the CM, cGMP regulations require that they be quarantined and tested before they are released into inventory. The type of testing required includes identity and potency, microbiological compliance, and heavy metal compliance.?

If you want to know more about identity and potency tests as well as microbiological and heavy-metal testing, read our full blog here: https://www.nutrasciencelabs.com/blog/whats-the-process-for-manufacturing-dietary-supplements

Step 7: Bench Work

Once all of the raw materials have been released into inventory, the CM will next conduct bench work, A.K.A., an R&D batch. This is where the raw materials will all be mixed together, and a limited number of tablets and capsules will be produced in the lab to ascertain that the formulation will work in a finished dosage form. Depending upon the situation, the CM may provide samples of the tablets/capsules to the customer to evaluate. Once the customer approves the samples, the CM can then move onto the pilot batch.

Step 8: Pilot Batch

Using what they learned during bench work, the CM will next run a pilot batch of the product on the actual production equipment. This is necessary to determine that the product will run correctly on the equipment during the actual production run. If there are any issues, the formulation may need to be adjusted, which may require approval by the brand owner. If everything goes well, the CM will then move onto the full production run.

Step 9: Production Run and Testing

The production run is when the finished product will actually be produced. There are several steps in the process, including some additional testing that needs to be done. This includes uniformity of mix, content uniformity, dissolution testing, and a repeat of the tests done on the raw materials (identity and potency, microbiological compliance, and heavy metal compliance).

Again, for a detailed explanation on testing, please read the full blog on our website: https://www.nutrasciencelabs.com/blog/whats-the-process-for-manufacturing-dietary-supplements

Step 10: Testing of Finished Products

Once the finished products from the production batch have been made, a repeat for the same types of tests done on the raw materials is performed.

The CM will then produce a certificate of analysis (COA) which will be sent to the brand owner. Once the brand owner approves the COA, the finished product can be shipped to the customer’s distribution facility, and the manufacturing process is complete.

Do you still have questions about the process of manufacturing dietary supplements? Our team possesses over 120 years of industry experience and would be happy to assist you! Call 855-492-7388 to speak to one of our representatives or send us your request to receive a free price quote if you already have your requirements.