After spending about 20 years working in the nutritional supplement sector, many of which involved formulation and contract manufacturing, I can categorically state that going with the quickest and least expensive supplement contract maker is frequently the wrong choice. A high-level overview of the normal manufacturing process with a contract manufacturer will help me to express myself (CM).
The Manufacturing Process for Contract Supplements
How a good supplement manufacturer may assist you in creating a dietary supplement that complies with GMP is as follows:
- The customer files a request to the CM for pricing information.
- The consumer receives the pricing quote from the CM.
- The customer sends the CM a purchase order (P.O.).
- The necessary raw materials are ordered from vendors by CM.
- Raw materials arrive at CM.
- Raw materials are tested in quarantine.
- Raw materials are freed from quarantine after passing tests.
- The CM conducts bench research to assess whether the formula will function in a finished good.
- Depending on the circumstances, the CM may offer the customer samples of the product that is being produced for evaluation.
- The client accepts the samples.
- A pilot batch is run by CM before a production run.
- CM manages product batch production and packaging.
- CM tests the final product in accordance with the requirements.
- The finished product is approved by the customer after a visual inspection and an analytical certificate.
- The product is delivered by CM to the customer’s distribution center.
How long do you believe it generally takes for a new custom order to complete this full process?
The time it takes to complete a product after receiving a purchase order is between 12 and 16 weeks. Reorders can normally be fulfilled in 8 to 12 weeks, depending on the contract manufacturer.
What’s taking so long? Most of the time, it involves ordering the raw materials and then waiting for them to arrive.
How do I order raw materials for dietary supplements?
In addition to various nutraceutical sidekicks, a well-formulated dietary supplement frequently includes one or more hero components. These “hero” components frequently have strong human clinical studies behind them, enabling brand owners to make persuasive structure/function claims about their product (s).
Naturally, these “hero” chemicals also tend to cost more per kilogram than alternatives, which some contract manufacturers may offer as less expensive options, but which typically lack research to back up claims. In any event, it could take some time for your contract manufacturer to get the hero ingredients after a P.O. because they might originate from domestic or foreign suppliers. been positioned.
Let’s use a probiotic as an illustration of the substance in question. Probiotic components are often prepared to order because they include living bacteria. They literally need to be raised on a natural medium, which takes time. Probiotics can actually take six to eight weeks to grow. If those probiotics are from Italy, as is frequently the case, the finished product will need to be transported abroad, which normally takes 1-2 weeks.
Isn’t there a quicker, more affordable option?
There is always another option. Instead, you may select a probiotic ingredient that the contract manufacturer currently has on hand, eliminating the need for further waiting. But pause for a second and consider your options.
Probiotics are alive and have a limited lifespan. It is extremely possible that they have suffered a substantial loss of efficacy if they have been stored on a warehouse shelf for months by a contract manufacturer. This means that the probiotic may have little or no activity when it is added to a completed product. As a result, your product will not work as intended, and any claims that were going to be supported by the probiotic are now inadmissible.
How are the basic materials for dietary supplements tested?
Raw materials must be examined and quarantined whenever they arrive at a CM in accordance with cGMP requirements. What then goes into testing? The following tests must be performed on raw materials:
- Both identity and power
- conformity with microbes
- Metal conformity with heavy
An established methodology must be used to test the raw material ingredient for identity and potency. Not only must that technique be followed, but if the contract manufacturer doesn’t already have the standard, it must be bought. If you weren’t aware, a standard is a verified sample of the substance used in raw materials that the CM’s laboratory will use for comparison. Using the proper scientific tools (like HPLC), the raw material will be compared to the standard to check if it matches. Identity and power can be established in this manner.
To ensure that the raw material doesn’t contain harmful concentrations of germs like E. coli, it must then be tested for microbiological compliance. For this, specialized tools in a different microbiological lab will be needed. Due to the fact that not every contract supplement producer has an internal microbiological lab, it may be necessary to transfer the raw material to a third-party lab for micro-testing. In other cases, contract manufacturers don’t even have access to a typical analytical lab, necessitating the use of a third-party lab for all testing. Of course, when a raw item is delivered to a third-party lab for testing, you have to account for extra time (perhaps 2 weeks).
Finally, testing for heavy metals like lead, mercury, cadmium, and arsenic must be done. Not only is this necessary and the proper thing to do, but failure to comply with the criteria could result in costly fines if your goods don’t fulfill their stricter heavy metal limits.
Additional Points to Bear in Mind as New Brand Owners
You can see from these examples how ordering and evaluating raw materials can affect how quickly products are produced. But be honest: if a product hadn’t gone through all of these tests, would you personally want to consume it or give it to your family? Now consider that ordering and testing of raw materials are just one of the variables affecting costs and schedules. Throughout the entire production process, additional testing and quality assurance procedures are used, each with its own effects.
My Last Words of Wisdom for New Brand Owners
Quotation for Owners of New Dietary Supplement Brands
Therefore, it should raise a red flag if the supplement contract manufacturer you’re chatting to offers or promises you much lower cost and a quicker turnaround time for the finished product than other service providers.
Depending on your personality, you should also be asking the following questions to yourself and others at the same time:
What sets them apart from the other contract manufacturers I’ve spoken to in terms of speed and price?
Where could they possibly save money?
Do they make use of inferior raw materials?
Are they carrying out all required product testing?
Do they adhere to the cGMPs?
When it comes to the manufacturing of dietary supplements, the proverb “You get what you pay for” has never been more applicable. Can you, as a brand owner, afford to put your business’s reputation at risk by placing purchase orders with a contract manufacturer who promises lower prices and quicker turnaround times inconsistent with the development of high-quality products based on cGMP compliance? Make informed decisions. Your reputation depends on it, as does the reputation of your brand.