In this series, we are briefly going over each of the steps we are assisting a new client with creating and launching their new dietary supplement product for their new dietary supplement company. In the last installment, we reached client approval on the product formulation, and created a purchasing specification that could easily be sent out to potential contract manufacturers to quote pricing on.
The purchasing specification we create is very similar to the finished product specification that will need to be created, but omits some of the needless details such as methods for determining that specifications are met, and areas for QC signatures. However, it is detailed enough so that little if anything is left to interpretation in the quoting process. The purchasing specification should contain all of the details for the packaging components such as bottle size, bottle color, plastic type, lid type, scoop size, seals to be used, desiccants, etc. For the actual dietary supplement, you should include things like the dosage form, net quantity of contents, Serving Size, ingredients to be used, label claims to be met, and any other information that ensures that the product is formulated correctly. You might also include what is not allowed, such as certain allergens, non-organic materials, types of fillers, etc.
Because we have relationships with so many contract manufacturers, and routinely visit many of them on behalf of our clients, we selected three that would be good potential fits for this client, and sent them the purchasing specifications for quoting. One manufacturer’s response and excitement for this new unconventional product was so good, that even though their pricing was a little on the high side, our client wanted to move forward in qualifying them as the supplier for the project.
The client, using our set of standard operating procedures (SOPs) for an own label distributor (SOPs to be discussed in a later piece), completed a paper audit, and gave the supplier a preliminary qualification pending an on-site visit. The client contracted us to go with them to the facility to conduct a full audit, and it went very well. Although tedious and overlooked by many, qualifying (and re-qualifying) your suppliers is a requirement of the current Good Manufacturing Practices for dietary supplements. The purchase order was made shortly after the visit.
Once the purchase order was made, and a 10-12 weeks lead time was assigned, there was much to be done in the meantime. Stay tuned for the next steps in the process. If you need assistance with creating purchasing specifications, qualifying your suppliers with paper or on-site audits, or referrals to manufacturers we know and trust, contact us today!