Sid Talks Testing

5/18/15

Demystifying Lab Testing: Handling a Failed Sample

With so many companies getting more serious about product testing, it’s important to note that there is a learning curve for those that don’t have experience with a robust testing program. One of the first things to learn is how to handle a failed sample, and the first priority is to identify why.

No one wants a failed sample but the fact of the matter is, it happens. Recently, with all the negative publicity that the NY Attorney General has sparked, the number of companies finally starting to test their incoming ingredients or finished products more accurately, or at all, has been increasing. This has, increased the rate of sample failures we have been finding, giving rise to a lot of perplexed companies trying to figure out what the origin of the problem is, if they are doing things according to the cGMP’s, 21 CFR Part 111 for Dietary Supplements.

How many times have you sent in a sample to be analyzed and it failed to meet spec, whether for botanical ID analysis or quantitative analysis? I can honestly say that whenever we fail a sample, it is one of the more frustrating and time consuming situations in my days and weeks following. Additional work goes into assuring the sample failed due to its’ deficiencies rather than a lab error.

As an Analytical Testing Lab that has dealt with these problems for many years, we have a fairly rigorous method of investigating failures to rule out operator error. This may involve repeating the analysis with the same or a different method, etc. But, more importantly we always perform a very thorough investigation of the submitted test sample by confirming that we have all the necessary information on our Sample Submission Form so that we can appropriately prepare the reference samples in the same or similar way to that used when the test sample was prepared. If this information was not available or was inaccurate, the samples are more likely to fail.

There are many reasons a sample can fail and in order for the testing lab to be confident in their results, it is always essential for our sample submission form to be filled out accurately, so we can compare the right sample & plant parts to the test sample. Some of the common possibilities are that the test sample was extracted in a very unique way that has pretty much removed all of the unwanted phytochemical constituents, leaving typically only one component of interest, that is not unique to the plant it was supposedly derived from, leaving us no choice but to fail the sample as not being chromatographically equivalent to the reference samples it was compared to.

One other obvious cause for failure is the test sample is simply not what it is supposed to be. It is not the same genus and species as the reference samples used to compare with. This is where the rubber meets the road! Given the fact that ingredient suppliers and/or manufacturers do not have to prove by third party testing that they have what they say they have, same genus and species, the buyer must be aware of the many possibilities. Since the ingredient supplier/seller does not have to prove that he is supplying the right material, the buyer, manufacturer, distributor has to perform testing to document its’ identity.

So, as a consequence of following the law, many companies are finding that they are not as aware of their supply chain as they should be. There are some ‘sloppy suppliers’ that are just not careful or as concerned as they should be about the crude raw materials they are buying to then redistribute to the Dietary Supplement Industry. When sourcing from brokers and aggregators, buying cheap will likely mean higher testing costs to guard against inferior material. Be prepared to do what it takes to assure the quality and identity of those ingredients.

For now, there is going to be a period of adjustment until companies realize that botanical identification is important, even before quality can begin! Until that time comes, the learning process will be at work and many companies are finding that many of the samples they have not been testing or adequately testing until now, are not actually what they were supposed to be and now they have to go back to their suppliers and reject the misidentified material, possibly leaving the company stuck with something they can’t legally use unless they accurately identify it.

Cases of “mistaken identity” come in cycles, and we are always monitoring what products are likely to be problematic, and take extra care with those. I’ll go into more detail about this in a future newsletter.

Two lessons we as an industry with increased focus on testing need to learn:

1. That failed samples are inevitable and with a proper and adequate monitoring system, aka, a good Quality System in place, that dictates just how to correct the issue and prevent the same thing from happening again.

2. In order to minimize the predisposition of this mistaken identity problem being perpetuated by sloppy suppliers who don’t have to test their raw materials, all affected parties, the buyers, etc., must put pressure on the other end of the supply chain, so that they take the problem more seriously or they will have to lose the business. There are good suppliers out there, you just need to shop around, and do the work to verify them, until you prove they are worthy of your business.

The bottom line is that too many companies do not have total or enough control over their supply chain and they need to push back until they get what is required by law. With this new commitment to proper testing, the industry will continue to rise to the occasion by constantly improving the quality of their products making this a win-win-win situation for all concerned parties including but limited to government, labs and last but not least, the Consumers.

Sidney Sudberg
CSO/President

Sydney Sudberg

Each month Sidney Sudberg, Alkemist Founder & CSO, helps to demystify the science behind testing by discussing a testing-related topic.

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