Not all dietary supplement contract manufacturers are created equal. Much like interviewing a job candidate, you should be asking your potential or current dietary supplement contract manufacturer a number of questions to ensure they are dependable and reputable, as well as a good fit for your business goals. As this is a business relationship, you will want to make sure your contract manufacturer fits your expectations and needs. Many retailers and business owners who do not know the ins and outs of a dietary supplement contract manufacturing company, however, may not be aware of important questions they should be asking. As you’re brainstorming your list, consider these important factors.
1. Ask about the history of their company and how long their facilities have been in operation.
An experienced and long-standing dietary supplement contract manufacturer should be proud to tell you about their history and facilities. If this information cannot be found on their website or they do not have a good answer to give you, this should put up a red flag that they may not be experienced or have a good reputation in the industry.
2. Ask about their available manufacturing capacity for tablets and soft gels.
Having large product run capabilities for tablets and soft gels is essential when it comes to a dietary supplement contract manufacturer. Even if you are not selling large quantities yet, you will want to have this opportunity available to you in the case that your product line achieves greater success.
3. Ask whether they provide all end-to-end solutions in-house.
Many dietary supplement contract manufacturers outsource some steps in the process or do not provide certain solutions/services at all. This creates the need for a middle man which will likely cost you more money and slow down the process costing you time. This typically will also cause complications as things can get lost in translation. In many cases, this will even result in a finished product that is substandard or not exactly what you had wanted.
A turn-key solution contract manufacturer is one whose processes are entirely in-house from start to finish, such as Ion Labs. Manufacturers such as these can work together internally to make sure your product flows and follows your vision from formulation to graphic design and packaging.
4. Ask to see what certifications their facility has.
Certifications are extremely important in choosing the right dietary supplement contract manufacturer. You’ll want to make sure they are FDA-registered, GMP certified, NPA (Natural Products Association) NSF GMP certified, and SQF (Safe Quality Food) certified.
It is also beneficial to ensure they have member accreditations from the Private Label Manufacturers Association (PLMA), American Botanical Council, American Herbal Products Association (AHPA), and American Pet Products Association (APPA), if applicable. These will ensure you, and your customers, can trust the quality and safety of your products.
5. Ask about their regulatory process and if they can help you stay compliant in the US and export markets.
An experienced and trusted dietary supplement contract manufacturer will have a Quality and Regulatory team in-house whose attention to detail and keen observation, along with staying compliant with all cGMP and FDA regulatory requirements, ensures every product is of United States and export market regulatory standards.
6. Ask if they offer in-house lab testing.
Ensure that the dietary supplement contract manufacturer has an in-house quality control lab. A trusted dietary supplement contract manufacturer should have capabilities for full raw material, in-process, finished product and stability testing requirements. These include heavy metal, microbiological and strength/composition tests. This is crucial to ensure your products have been checked for contaminations, quality raw materials/ingredients, and a finished product that is pure and of superior quality.
7. Ask about their Quality Control process and how strong it is.
A dietary supplement contract manufacturer that is transparent in their processes to their customers can be depended on and trusted. They should have no hesitation in telling you about their Quality Control processes. A superior-grade quality control process will include the close monitoring of all processes on a continuous basis, ensuring tight adherence to all environmental and batch process controls. It should also include tight control of all documentation, including SOP’s (Standard Operating Procedures), batches, and logs. This ensures every batch is blended and formulated consistently, of superior quality and safety, and without error.
8. Ask what type of internal or external audits they perform.
An experienced and dependable dietary supplement contract manufacturer will maintain an internal audit schedule. This should include performing scheduled and unscheduled audits to ensure compliance with all FDA (Food and Drug Administration), cGMP, and CFR (United States Code of Federal Regulations) regulations for dietary supplements and OTC products; product quality requirements; and the company’s own internal standards and policies. These audits should inspect and assess production, quality control, quality assurance, label control, and packaging, among other departments. Quality-driven dietary supplement contract manufacturers, such as Ion Labs, will go beyond the requirements and perform frequent mock recall audits to better prepare themselves for their recall procedure, should they ever have to perform it.
Moreover, you’ll want to ensure that they challenge and test the raw materials that go into their dietary supplements. They should be tested for purity, strength, and identity. Aside from internal audits, a reputable dietary supplement contract manufacturer will also perform external, or third-party, audits with NSF International twice per year; as well as with Health Canada if your products may sell in this market as well.
9. Inquire whether they have relationships with vendors for raw materials and packaging to help negotiate better pricing.
An experienced dietary supplement contract manufacturer will have existing relationships with trusted vendors that they use time and time again. Becau