A good handshake still has value in the business world, but when it comes to choosing a contract manufacturing partner , it’s best to go beyond that handshake and get some key details in order.
One of the easiest places to start is the potential partner's certifications. While it’s not the tell-all of the manufacturing company you’re about to work with, nor is a necessity for manufacturing companies in our industry to have particular certifications, many insiders see certifications as a good indicator of quality.
Checking a contract manufacturer's certifications is an important early step in choosing the right fit for your manufacturing requirements. For example, a dietary supplement manufactured in a U.S. facility could be sold in Europe as a food item and, therefore, the U.S, facility would require a food certification, such as one from the International Food Standards (IFS) agency. A basic certification that most manufacturers go for is a third-party GMP (good manufacturing practice) registration. Business license documents are also a good thing to ask for from the start. From there it’s common to request third-party certifications, for example from NSF or the Natural Products Association (NPA). However, since FDA does not mandate these, some contract manufacturers may not opt to obtain these certifications and, therefore, a heavier burden is placed on the marketing company willing to work with such contract manufacturers. The manufacturer might be very open to a well-qualified audit, which can be a great sign of candidness and willingness to work toward a solid partnership.
Beyond certifications, there are a number of other criteria to consider. Some folks will jump at the lowest possible price, but I suggest taking a closer look at why some costs are there and how they deliver a safe product for consumption.
In choosing a contract manufacturer, another important step is ensuring delivery of a quality product on time. Determining the track record of delivery as scheduled is vital. Look for an excellent plant safety record, emphasizing safety and eliminating potential hazards. Strong partners will measure safety and have plant audit certifications to share their orderly and efficient operations with prospective customers. Product quality and safety is paramount; asking questions and going through the various processes that a contract manufacturer may or may not do will help you determine if you ultimately choose to work with that manufacturer.
Let’s take, for example, how a contract manufacturer performs testing. Typically, testing happens in three parts:
1. Identity testing to validate the ingredients about to be used in production.
2. Supplier qualification can be vague and is where those less committed to quality find their wiggle room. This qualification requires the contract manufacturer to go beyond the ingredient certificate of analysis (CoA), and this extra effort can and will require more testing on the various aspects of that ingredients' CoA. If a manufacturer accepts the CoA without verifying, it is likely better to work with someone else.
3. Final product testing includes analytical, chemical and microbiological results to help furnish a finished product COA. To run an HPLC or other appropriate tests for raw material validation or finished product COA, the contract manufacturer must have or obtain the proper reference standard sample. Inquiry on the part of the customer shows due diligence. Reference standards can be expensive, so this cost and availability should be addressed up front.