As in any industry, as it grows so do the innovations and advancements. At the same time, it can also lead to potential problems and issues. While some are just speed bumps in the road, others can be quite damaging.
Not all Contract Manufacturers in the Nutraceuticals Industry are created equal. Just as in any industry some manufacturers are more proficient than others.
Let's face it, just because someone answered "yes" to most of your questions about bringing your product to market, doesn't mean they understand your long-term needs.
We came up with our list of 11 questions to ask a contract manufacturer before you sign any agreement. How they answer these questions may mean the difference between a blockbuster and dud. If you're currently with someone, these questions can also serve as a good audit of your business relationship for current and future products.
1. What's your the lead time?
12 weeks? 10 weeks? 8 weeks? Whatever lead time they give you should allow for a small test run to identify any potential problems, material ordering and delivery. It also must include initial and final laboratory testing to meet or exceed FDA requirements, documentation and, of course, the production and packaging of your finished product. Just go with your gut, if their lead times "feels too short," it probably is.
2. Do you offer trial runs?
A trial run — also called a "pilot batch" or "sample order" — can be a useful tool to test market a new product. It allows you to gauge consumer response and make any needed adjustments.
3. What up-front costs are typical?
Printing set up, custom label design, unique packaging costs and even market research are all part of designing and launching a new product. Even switching contract manufacturers has its own costs in both time and money. The best contract manufacturers understand this and offer consultation services, volume discounts, partnership opportunities and turnkey solutions to minimize the effort and costs involved in new product offerings.
4. What if I need to scale up?
Scale-up operations are an invaluable asset for new businesses or established businesses opening a new line of products. Contract manufacturers want to extend their partnership, so it's in their interest to scale-up operations, including long-term collaboration and “as needed” orders.
5. What type of testing do you do?
A common strategy is to utilize third-party testing in a ISO qualified lab to ensure compliance with FDA-regulations and the ability to answer your customer’s demands for high quality finished products.
6. What certifications do you hold?
Here are some industry recognized certifications that are crucial:
- cGMP(current Good Manufacturing Practices) & NSF compliance in accordance with 21 CFR part 111 for the manufacture of dietary supplements and nutraceuticals.
- Memberships in groups like the Private Label Manufacturers Association shows the company is active in the industry and is aligned with quality expectations.
7. Are you FDA-Registered?
Again, verifying this is crucial. They should be an FDA-registered production facility and fall under specific designations in the Federal Code of Regulations. The FDA does conduct random inspections from time to time so it may be good to ask when the last time they were by.
8. Do you carry liability insurance?
Another obvious question but easy to forget. You want to make sure their insurance covers various areas. Vesta Nutra, for instance carries general, umbrella and product insurance. Our insurance covers finished products sold to our customers, protecting them in the event of a manufacturer error.
9. What regulatory, safety and quality documentation is available?
Your contract manufacturer should provide a Certificate of Analysis (CoA) detailing compliance with product specifications, lab testing results, methods, and expectations, demonstrating the identity, purity, strength and composition of the finished product. They should provide you the CoA at no additional cost for any finished product manufacturing purchase.
10. How long have you been manufacturing dietary supplements?
This question is supremely important because their response will give you insight into how dedicated they are to your needs. The length of time a company has been around is often correlated with their level of expertise. With such a booming industry, it can be challenging to find a company in business more than 15 or 20 years.
11. Tell me about the sourcing of your materials?
The answer to this question is at the top of the list for most businesses when choosing to outsource manufacturing. Like the prior question, their expertise in the materials/ingredients associated with your product is key as well as making sure that it comes from a quality source or supplier. Do they have an effective supplier qualification program in place to meet FDA expectations. Ultimately you want to make sure that they fully capable of handling your needs, not only efficiently but securely. Nobody wants to deal with the cost and image repercussions of a product recall.
Of course, this list doesn't represent EVERY question you need ask in your effort to size up a contract manufacturer, but these are questions you should ask. Frankly, HOW they answer your questions; is just as important as WHAT they say! After all, they should know their business if they want your business!
Feel free to reach out to us at Vesta Nutra to find out more about contract manufacturing in the Nutraceutical and Supplement Industries. You can email us at firstname.lastname@example.org or give us a call at 888-55-VESTA.