Manufacturing Perspective:

Looking Beyond a Supplement Certificate of Analysis

By: Mike Finamore - CEO

As everyone has noticed over the last months, there has been a considerable effort made by online and traditional retailers to gain a better understanding of the products on their shelves or store fronts. While there are considerable differences in these retailer-driven programs, they all share an unbending requirement to have a representative Certificate of Analysis (C of A) presented for their review.
Unfortunately, the presentation of a C of A results in more questions than answers. While a C of A can provide some information about a lot of product, without other complementary information it is merely a “snapshot in time” of a product, and a poor substitute for a robust quality system.
Most of us are aware of the contents of a C of A – the physical characteristics are listed for a particular item and the analytical results of testing for key components of the product are also recorded. Traditionally, this completed document is suitable to be presented by the Contract Manufacturing Organization (CMO) to the Brand Owner to help the Brand Owner release the product to market.
However, and despite the best intentions of regulators and others, this document does not offer the security to the marketplace without its sister documents. The C of A presumes the actual manufacturing was done in a GMP environment and that each of the ingredients were approved and suitable for the purpose intended. Assumptions are also made about the stability to the item once it reaches the market and are other critical considerations of the product met to ensure the release to market was done correctly.
The C of A itself is a complex document but has limitations. Many times, the information on the C of A is taken from small samples through a production run, which may give a false sense of security if the manufacturing process itself is not reliable. Additionally, a CMO is not required to test every ingredient on the C of A each time the product is made, leaving it in the hands of the Brand Owner to determine the extent of testing required before the product is released to market. Finally, should the Brand Owner engage a 3rd party laboratory for testing, there might be conflicting information generated when compared to the CMO test results, leading to a potential misunderstanding by the Brand Owner or the retail customer about the viability to the product.
So, what is the Brand Owner to do? The answer is not to send the supplement to a 3rd Party Laboratory and test for “everything” in the product according to the finished product specification. As stated above, the nuances of each product can create headaches without a reasoned, measured approach to analytical testing done in conjunction with the CMO.
What about using an ISO 17025 accredited laboratory, as has been requested by many retailers? Doesn’t this solve the testing problem? An ISO 17025 accredited lab demonstrates that the lab has a documented quality system and that they are proficient in running the assays they are accredited for. However, even an ISO 17025 laboratory will have assay issues with supplements and will encounter matrix interference- so while ISO 17025 accreditation is a gold standard for a testing laboratory, there is still the need for a working relationship between all parties.
Another step would be to have the products certified by a Certification Body (CB) to national standard (i.e., NSF/ ANSI 173). The CB will evaluate all the raw materials used in the supplement, they will review the labels and Supplement Facts Panels for accuracy and will test the product. Typically, the CB’s lab is accredited to ISO 17025. Usually, part of the certification process is an audit of the manufacturing facility, hopefully using an audit procedure done also to a national standard, NSF/GRMA 455. The CB will require regular (usually annual) reviews of the product and manufacturing operation to ensure “ongoing compliance” with the standard the product was certified to. Since this is done in partnership with the CMO, this can help create a seamless process for all parties in the relationship.
So, the answer is having your product certified and all the consumers and retailers are happy – right? If only it was so easy! Between raw material variability, seasonality of a harvest and other common-sense issues, there are always considerations to be made when creating testing and reporting parameters for the C of A. Therefore, a strong quality system can help mitigate and explain any issues with a particular lot and demonstrate the Brand Owner’s awareness of the product they are marketing.
It is for these reasons that a full series of Quality documents need to be in place between the CMO and Brand Owner. The product specification would determine the way the ingredients should be tested, and the underlying quality agreement would assign responsibility for these results. Additionally, the Brand Owner would ensure their chosen 3rd party laboratory would conduct testing on their product using the same methodology as agreed to with the CMO during the design phase. By not allowing for a gap between the CMO and 3rd party laboratory, this resolves many testing issues caused by matrix interference, trademark ingredients, and differing laboratory methodologies.
One final note – even the best laboratories (ISO 17025 or not) may occasionally report disappointing results – but all is not lost for the Brand Owner! A strong relationship with the Laboratory would allow for an investigation by the Lab to ensure there was no mistake on their end. First and foremost, the Brand Owner would make sure the laboratory was running the correct method for their product – the one that is either scientifically valid or validated and is appropriate for your supplement matrix as determined in the Product Specification. Also, an Out of Specification Investigation (OOS) and a retest using 3 new samples, each with their own analytical preparation step, should also be requested.
While there still may be differing results at the end of the process, the Brand Owner’s robust quality system will allow them to proceed with confidence in determining the root cause of any issue. The results in the testing may be inherent to the specifics of the product, and by doing all of the aforementioned items you will have proof all of the ingredients were put into your supplement at the label claim levels and was made in compliance with the regulations.
The requirement for a C of A by retailers is a strong step in demonstrating their commitment to the items on their shelves and puts brands on notice to be aware of their responsibilities. However, while this is a big first step, its undeniable that the next steps in this process will offer even greater assurance that both the marketplace and its vendors look beyond a “snapshot in time” offered by a C of A to ensure only the highest quality supplements get to market.