Break out the shoe leathersometimes solving a modern problem requires old-fashioned tactics.

Recently, FDA called out the responsibilities of private label distributors in several warning letters. For instance, in an April 2013 letter to Pristine Bay, FDA said, As a distributor that contracts with other manufacturers to manufacture, package or label dietary supplements that your firm releases for distribution under your firms name, your firm has an obligation to know what and how manufacturing activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement cGMP requirements." The letter went on to say a distributor/marketer of dietary supplements has the ultimate responsibility to ensure its products are not adulterated.

Since theres no sidestepping the responsibilitynot that youd want to, because its ultimately your brand and your reputation at stakehow do you go about making sure your products are manufactured according to the latest cGMP (current good manufacturing practice) standards? And how can you be sure your products are unadulterated and true to your label? Begin with the basics:  educating yourself. Find out what the dietary supplement cGMP requirements are so you can speak intelligently and ask questions about them. Then, investigate third-party certifications such as INFORMED-CHOICE and NSF International. Learn what certifications are available and which ones you want your contract manufacturer to have. The quality certifications a contract manufacturer holds are indicative of its overall quality standards.

Sole Searching

Seeing things in-person is another valuable throwback method of doing good business. Arm yourself with knowledge and then visit the contract manufacturer. A personal audit will go a long way to letting you see if a manufacturer is a fit. A face-to-face meeting lets you take the measure of a company, its staff, its policies and its procedures. Reviewing paperwork remotely can only divulge so much. Schedule a visit once youve identified a contract manufacturer with the certifications and quality standards you desire. Theres no substitute for auditing a facility in person. 

When you visit a contract manufacturer, make sure you tour the entire facility, from receiving to shipping. With proper attire, you should be able to view the entire manufacturing process. One of the simplest ways to tell whether a manufacturer takes its qualityand therefore the quality of your products seriously is to see if the facility is visibly clean and in good repair. As you tour the facility, ask questions about how the quality of inbound raw materials and finished product is ensured. Is every container in every lot of raw material tested for authenticity and contamination? What is the standard of materials used?

How is equipment cleaned and maintained to avoid cross-contamination? Will the manufacturer source and handle questionable ingredients or banned ingredients (e.g., stimulants and steroids) in its facility? If so, beware that these same ingredients could one day contaminate your product. Find out what testing equipment is onsite and ask about the equipments' purpose.

The best guideline is to ask questions and then ask more questions. Your brand and your reputation are on the line. Be sure youre comfortable with and trust the company thats going to manufacture your product. Is the company doing the bare minimum required by FDA or do they go above and beyond to increase their quality standards? For example, are raw materials tested for heavy metals content?

Tying it all Together

In the end, youll want to partner with a contract manufacturer that treats your brand integrity as its own. Working with a manufacturer that continually communicates with you regarding your product consistency, quality and label claims is key because maintaining quality is an ongoing process.

It takes effort, time and money. And remember, if the price youre quoted to make your product is too good to be true, then it probably is. Maintaining rigorous quality standards and sourcing authentic, unadulterated raw materials comes at a cost. Its probably not what you want to hear, but the cheapest contract manufacturer you can find is not likely to be the best one for your business in the long run. Quality is a great long-term investment for your business.

Joe Archer is the vice president of sales and marketing at All American Pharmaceutical.