It has been over a year since the final installation of Current Good Manufacturing Practices (cGMPs) designed to raise and regulate the quality standards of the dietary supplement industry. Subsequently, the FDA has taken serious steps to make sure that supplement manufacturers fully implement the cGMPs. As the FDA continues to conduct its audits, several companies have either been issued warning letters or have been forced to cease their operations because of their inability to meet cGMP specifications. As a result, many supplement business owners are being forced to search for a new manufacturer to help that can help them meet their manufacturing needs. Unfortunately though, many of these people may not know the questions to ask a potential supplement manufacturer.
Here are 5 pertinent questions you should be asking your prospective supplement contract manufacturer, especially if you’re starting a supplement company.
Do they outsource any of the services they advertise? You need to make sure that all the manufacturing services a contract manufacturer advertises take place within their own facility. Why? Any service that is outsourced does not come under the full supervisory control of the contract manufacturer, and therefore there is danger of quality standards being compromised.
For instance, if a contract manufacturer offers warehousing and order fulfillment, you should be able to see where your products are being stored and make sure that the environment is conducive to storage. Check how inventories are maintained and how quickly a shipment is dispatched from the time an order is issued. If a manufacturer advertises that they have an in-house graphic design department, you should make sure this department exists on the premises so that you have direct access to their designers. The same holds true for a manufacturer who advertises custom formulations and in-house lab. You should be able to meet with the formulators to discuss your product and check out their lab facility.
Do they answer calls? You need to make sure that, when you call your contract manufacturer, someone on the other end will answer your call.
A manufacturer that employs an accessible and knowledgeable team of customer service representatives is an indication that they view client satisfaction, trust and lasting business relationships as top priorities. Besides, if there’s no one to answer your calls, how can you get your product line off the ground?
Can you take a complete tour of their facilities? Tour the facility/building of a supplement manufacturer before you make a decision to contract with them.
It’s important for you to see how hygienic the facility is maintained. Go through the entire manufacturing process right from the entry of raw materials and their inspection to the testing of the final product and shipment.
Things to observe while touring the facility:
- Standard operating procedures (SOPs)
- Specifications raw material and finished product
- Quality control (QC) in the areas of manufacturing, packaging, labeling, holder and storage controls
- Master and batch records
- Change control
- Complaint handling
Ask questions such as: does the manufacturer qualify its supplements and what are the processes that are in place to ensure integrity of the supply chain? Ask what steps are being taken to ensure that the specifications on the label meets with the ingredients found in the supplement. Make sure that all personnel are suitably qualified for their jobs. Ask them whether internal audits are performed and what steps are taken when deficiencies are identified?
Do they exhibit at trade shows? You should be able to see your current or prospective nutraceutical manufacturer exhibit at trade shows.
Major supplement manufacturers will exhibit at industry-related trade shows regularly to promote business, reach prospective clients, gain media attention, keep up with industry trends/latest developments, network with vendors and build relationships with others in the industry. Supplement manufacturers not exhibiting at trade shows may not be legitimate or just may not have the infrastructure to handle bigger business opportunities. Either way, not having a presence at trade shows is generally not a good sign.
Is your prospective contract manufacturer in the media? Make sure the supplement manufacturer you plan to work with has a respectable image in the industry and has been in business long enough to establish a well-known reputation for manufacturing high-quality products.
Check out social media sites by Googling the manufacturer. Read through what others in the industry have to say about the manufacturer on message boards, blogs and forums. Ask members in these online communities whether they have heard about the manufacturer you are considering and what their thoughts are. These people are usually knowledgeable, experienced and unbiased so their input while not a decisive factor, could be valuable to you as you make your decision.
Read through industry publications such as Nutritional Outlook, Natural Products Insider, etc. to see whether the manufacturer is running advertisements.
You also may want to find out if they have won any major awards and confirm this information by speaking directly with the magazine or other reliable news sources. Additionally, you may want to check out company rankings in Inc. 500|5000 to see if the company is in good financial standing. The last thing you want to do is contract with a supplement manufacturer that’s on the verge of going out of business.
Third-party GMP-certification offers additional assurance
Make sure you are thoroughly satisfied with the operating procedures, documentation, QC and QA processes and the steps taken to fully comply with cGMPs. If a contract manufacturer is already GMP-certified by a third party such as the NNFA, there is a sufficient guarantee that the manufacturing facility already has the necessary processes in place to easily comply with cGMPs. Such manufacturers can provide you with a long-lasting partnership for producing high-quality supplements efficiently, quickly and with a high degree of emphasis on superior quality manufacturing.