In my travels of working with clients and discussing dietary supplement product development and bringing these new products to market, I often encounter a multitude of questions. Most of these are common questions or concerns about the product itself, such as: “What new and unique ingredients are available?” “Will this item create excitement in the field?” “How will this product benefit our distributors and end users?”
All product-development teams working on new product introductions should ask these questions. However, the more important questions are often overlooked. In the current regulatory environment, the manufacturing process has become more complex and time-consuming. Beyond choosing a cGMP (current Good Manufacturing Practices) facility, let’s look at some of the obstacles that are often unforeseen in the manufacturing process.
Before committing to a manufacturer, have your regulatory department set up a tour to audit the manufacturing facility. What is the manufacturer’s history? How long have they been in business? Do they have certain competencies that fit with your new product launch? Are they strong in encapsulation but not suited to manufacturing softgels or liquids? Do they operate under the current cGMPs as set forth by the FDA? Has the manufacturer been audited by a third party, such as NSF or NPA? Remember, the FDA does not certify any manufacturer; it simply licenses the facility. It is up to the manufacturer to make sure it is compliant with the current cGMPs. This is where the third-party certifying firms come in to play in helping the manufacturer understand and comply with the required FDA cGMPs.
Make sure to have a confidentiality agreement in place during product development and a subsequent manufacturing agreement when moving into that phase of the final product. The manufacturing agreement will serve as a road map as to who is responsible for certain aspects before, during and after manufacturing the product.
Will the manufacturer have an assigned account manager to guide you through the process and answer any questions? More important, make sure the account manager will be your advocate. This person will be the contact point for all aspects of the project—from the status of research and development to the receipt of purchase orders to tracking the production timeline. You should be able to contact this person at any time in the process and get answers on the status of the project/ production.
Research & Development
How well staffed is the R&D department and how qualified are they to help you turn your ideas into reality? Have a level of comfort with the amount of experience the head of R&D and his/her supporting staff possess. Choose a manufacturer who has sufficient staffing in the R&D department to ensure they can juggle multiple projects.
How will the ingredients in the new product be looked upon by the FDA and other regulatory agencies? Are any of the ingredients currently under scrutiny by the FDA or other agencies? Many of the new ingredients currently on the market are facing more rigid analysis in determining whether they are safe for consumption.
Can you deliver a quality, efficacious product for a competitive price? In other words, are the ingredients that you choose for the product cost-prohibitive? If the cost is excessive, does the manufacturer have the knowledge to help you with alternatives? The recommended use in researched ingredients may exceed a reasonable serving size. Ideally, a customer might want a 60-count bottle but, in reality, the optimal dosage may dictate significantly larger quantities.
How many vendors does your manufacturer qualify for each raw material? Ideally, you want the manufacturer to qualify no more than two or three raw-material suppliers, with one primary vendor, which ensures product consistency and adequate supply.
Once you have settled on a desired formulation, what risks are involved in acquiring the raw materials? Are all ingredients readily available for purchase by the manufacturer in a manner that fits established lead times? If not, what provisions must be implemented to ensure inventory levels are sufficient to continue uninterrupted sales efforts? Many manufacturing partners are willing to inventory some of the raw materials that may incur delivery delays with the understanding that if you change formulations or discontinue the product, you will make the manufacturer whole at the end of the day concerning their investment.
Does the manufacturer have any additional international certifications, such as Australia’s Therapeutic Goods Administration (TGA) or Health Canada? Many of these international certifications are quite expensive and not easily obtained. Will the manufacturer help you obtain Certificates of Free Sale (COFS) from the regulatory agencies in their state for your export needs? Some manufacturers will have a designated person to guide you through the international paperwork requirements.
Does the manufacturer offer a qualified person who is up to date on FDA labeling requirements to help you develop a compliant label? These requirements are continually changing, and it is important that the manufacturer keeps its labeling staff up to date on current regulations. This is achieved by offering continuing education on a regular basis. The label is the face of your product and the most likely to be reviewed by the FDA. Make sure you have a qualified person available so your label is compliant from the outset of the project.
Can you work within the manufacturer’s lead time parameters? All manufacturers have lead times that can vary based on a number of issues, including raw materials, packaging components and current production commitments. These lead times can exceed eight weeks. Lead times may be impacted further if the customer is supplying any of the components for the production. Many times delays occur when customer-supplied items arrive without the proper documentation. Make sure to check with your account manager well in advance to determine the required documentation. Let us not forget about the current regulatory issues that all manufacturers face in testing product at multiple stages of the manufacturing process.
Is your manufacturer capable of meeting your needs in the event of an unexpected sales increase? Are they willing to shorten lead times, when needed, so you can meet your continued growth? The manufacturing process is intricate and requires detailed planning. It is often difficult to make changes to that schedule, but in some instances, when planning times exceed the actual time needed, there is a potential window of opportunity to work in an emergency production that helps keep a customer on track.
As you can see, manufacturing can become a tangled web at times, and companies can encounter many bumps along the way. Make sure to allow your product-development team and manufacturer ample time to bring this new product to market. Find a manufacturer that meets the majority of the criteria listed here and, ultimately, someone you feel comfortable working with in a long-term partnership. Manufacturers are constantly evolving in this regulatory environment and are working hard on a daily basis to stay ahead of the curve, allowing them to offer the customer more services and assurance in the manufacturing process.
I have always expressed to customers the difficulty of getting a new product off the ground by using the analogy of a horse race. I have said “getting the horses in the gate is the difficult part. Once you have the horses in the gate, running the race is the easy part.” Once the product is developed and becomes a reality through the manufacturing process, it is much easier to run the race on an ongoing basis.
David Daniel is the Director of Contract Manufacturing at Progressive Laboratories. For additional information, contact David at daviddaniel@ progressivelabs.com.