The Laboratory Notebook
Answering important questions about quality.
By Robert Green
This month we have a great general question on how to start up a new product from a quality perspective. It is very basic, but very important.
Q. I have been developing a new product and I am ready to have it commercially manufactured and begin my sales efforts for distribution. From a quality standpoint, are there things I should do before I manufacture a full order of capsules?
A. You’ve asked the right question at the right time! It is always cheaper, better, easier and less stressful to discuss quality programs moving forward than it is to discuss them in retrospect. In an industry as progressive as this one, it is always a good idea to have some analytical data to stand behind to assure that a) your product is composed of quality materials, b) the finished product meets specifications and c) the product will remain a quality product as it sits on the shelf. I know it sounds like a lot to do (and may be money to spend that you don’t yet have from sales), but it can be much more difficult and expensive for you and your lab to determine the cause of a problem should one arise later. Also, if you have a good relationship with your lab they may be able to help you incorporate this data into a nice marketing package that can impress your distributors.
So where do you start? You have a prototype, you know it works, you want to sell it. The first question to ask is, who is going to supply you with the raw materials for this product? Will you find your own supplier? Will your manufacturer supply you with the materials from its suppliers? Either way, it is a good idea to have at least a few materials tested for quality before going into production. Keep in mind that raw materials, particularly botanicals, come from all over the world. Between language barriers and shear distance itself, there may be miscommunication about exactly what you are receiving. Needless to say, dishonesty can also be a problem here. You must be vigilant to ensure that your product is not compromised and that you are not putting yourself at risk from the beginning.
The first step in this process is to make sure you get a certificate of analysis (C of A) or some sort of documentation from the supplier that says exactly what your material is (i.e. ginger standardized to 6% gingerols). Hold onto that C of A and send a sample of that material to your laboratory for gingerol analysis (your lab can help you figure out exactly what they should be testing if it is not obvious to you). When the results come back from your laboratory, make sure that the specification matches (plus or minus; a small margin of error). If the test results look good, you have yourself a good supplier of that material. You should also let them know that you are testing their material routinely to keep them on their toes. Now, of course, it is best to test a sample of each raw material used in the product, but if that is not feasible, testing at least a few will confirm some consistency in your supplier. Naturally, if you have more than one supplier, you would want to confirm the quality of each.
Once your material is qualified, it would be a good time to consider shelf-life testing to determine your product’s expiration date. We have explored shelf-life studies in past columns and there are several options here. The most cost efficient way is to do a real-time study, which involves simply keeping your product on a shelf and establishing pull points at which to analyze the product to determine if degradation has occurred. There is also a forced degradation study where a stability chamber is used to subject your product to varying temperatures and humidity levels. These are the two most common studies for your product. If you intend for your product to be refrigerated or frozen, those conditions could also be simulated over an established period of time.
I saved the part about checking to make sure your product meets specifications for last because if nothing else, this is the part of your analytical scheme that should continue for as long as your product is in production. It is important to send samples from different lots of your finished product to be tested to make sure that your product meets label claim. This is where a supplement can fall down if someone else gets their hands on it and decides to test it themselves. You always want to have current data relating to your product so that you are prepared for the toughest scrutiny. Also, as we discussed in our last column about mass balance analysis, the more data you have to support the composition of your product, the more you are safeguarded in the event that your manufacturer stops producing it. Ideally you would continue to test the raw materials on a semi-consistent basis, as well to make sure your product remains uniform, but if something does change in the raw material it will be noticed in the analysis of the finished product. At that point further analysis may be required to determine if the problem lies in the formulation or the raw material.
The bottom line is that preliminary and ongoing testing for quality is the responsible thing to do for both you and your customers. Testing is good insurance for a good product when you have the data to prove it. Testing can also save you a lot of money if you catch something on the front end, such as a bad batch of raw material, for example. Either way, quality is an important aspect to consider as you move forward with your new product. NW