Many good questions come our way throughout the year, but there is one very complicated
question that can cause a lot of stress for manufacturers and brand owners— why are my results
different from the supplier CofA? We’re here to help and give insight on testing and choosing the correct method of analysis.
To answer this question, there could be many reasons that the verification results might be different from the supplier’s CofA. First, the material could be sub-potent and verification testing proves it. But, there could be other reasons that cause a mismatch of test results to the supplier’s assay results. It’s important to realize that when following FDA guidelines and GMP practices, testing raw materials to qualify your supplier is required.
Many customers have never worked in a lab or understand method development and lab testing
procedures. Here’s some information to help explain how testing works. A key to obtaining results that match the supplier’s CofA is to use the same testing method as the supplier. When you review your supplier CofA, start by verifying the unit of measure for the active ingredients listed. Once you know the units needed for testing, then determining the test method that the supplier used will give method alignment to the lab. When different units are reported, and different test methods are used, there is a potential for failing results or results that don’t match. Having a good understanding and providing this information to the lab will make for a smooth and speedy verification. These steps will help the lab be organized, while saving time and money for you.
In some cases, you may choose to use a different method than what is listed on the supplier CofA. When going this route, it’s a good idea to test your material using compendial methods. If your supplier is not using a compendial method, and it is available, then asking your supplier to change methods may be an option. SORA Labs will run methods from compendial sources when they are available, which allows the same test method to be used for any similar supplied ingredient.

Customers can then compare different suppliers with the same ingredient using the same method.

This levels the playing field and compares apples to apples.
We encourage customers to do this often. For enzyme activity testing, we use methods from the USP/FCC or other compendia sources as much as possible. Enzymes generally have units of measure from the country of origin listed on the supplier CofA and may not be represented as the USP/FCC method. Running the material using the lab-proficient, compendial method allows the customer to compare the differences in the supplier material and make the best ingredient choices for their product.
Probiotics on the other hand, are little more complicated. Many probiotic suppliers run their own “vendor” methods for their materials. This causes testing labs like SORA to develop a large variety of methods to be able to test many suppliers’ materials. Trade organizations, universities, leading-industry companies and labs are working diligently to have more methods added to the compendia, but unfortunately, it is a slow process. SORA Labs has added a few compendial methods that are for similar genus probiotics to our ISO 17025 scope of accreditation, but we still run many vendor methods as well. Since a probiotic sample takes time to figure out, communication is necessary to find out what strains are included to determine the best method to run on each product. As the probiotic industry gets better method alignment between vendors, determining the correct test method will become easier.
In the meantime, two-way communication between all parties involved, is the key to accurately
testing these specialty ingredients. Let SORA Labs be your testing lab for supplier qualification and product verification. Call us today for a quote!

[vc_row][vc_column][vc_column_text css=”.vc_custom_1543440226481{margin-bottom: 0px !important;}”]When looking back at 2018, it’s easy to see how microbiology contamination can create a huge problem. Not being able to have romaine lettuce for salads at Thanksgiving was an obvious side effect to a massive recall because of contamination. Our blog titled, “Avoid the Testing Scramble-Test Early, Test Often” is a great overview of how testing from supply chain through manufacturing, should be handled. That blog addressed the need for developing prototype blends to determine testing interferences before the finished product is manufactured. It’s also important to realize that there can be many potential microbiology contamination points in the manufacturing process and testing microbiology early and often is also needed.
Microbiology testing needs to be strategic and organized. Every touch point in the process must be closely monitored—initial testing of the raw material, then in-process monitoring of equipment, belts, packaging components and final release testing before the product is shipped out.  Implementing testing specifications and tight controls of microbiology throughout the manufacturing process will lead to less recalls and increased consumer confidence. Monitoring the microbiology creates a simple quality check that keeps safety top of mind for the consumer.
Most of the recent news has been about Escherichia coli and salmonella contamination, and these are important tests indeed, but you can also look at general tests like total plate counts and coliforms to give you a quick check of quality and help determine if your existing cleaning procedures are effective or need improvement. It’s important to realize that microbiology testing is relatively inexpensive, but can pay huge dividends when helping to avoid expensive recalls and damage to your brand that can be hard to repair. Contact SORA Labs today for all your microbiology testing needs![/vc_column_text][/vc_column][/vc_row]

[vc_row][vc_column][vc_column_text css=”.vc_custom_1542053472949{margin-bottom: 0px !important;}”]It is a common myth is that one testing lab can handle every kind of test—the reality is that each lab usually specializes in a unique set of test methods. While it may be frustrating to need multiple labs for one finished product, the truth is that not every lab can be focused on every possible test that one product may require.  With this in mind, it’s important for customers to focus on how to get the most accurate quality test results for their specific products.
Even in-house labs usually won’t have the capability to be able to test every part of their manufacturer’s product lineup. Sometimes, it just boils down to expense of the equipment or the unique skill that is required to perform certain tests. It may not be feasible or cost effective to add these capabilities to the in-house lab. This is why a specialty contract lab can be a great choice to help fill in the testing gaps!
Contract labs, like SORA Labs, will market the testing for the expertise they have. This provides the volume of samples needed to keep the analysts skill level and method proficiency to the highest level.  These specialty methods are technique-based and require stringent pH and temperature controls.  Enzyme assays require the enzyme product to act on a specific substrate, causing a by-product reaction that can be measured.  The USP/FCC often includes the substrate catalog or part number in the method but this is not always the case.  Sometimes the reagents listed in the method are no longer available and suitable alternatives must be found. This can take some time, as finding an alternative substrate can be challenging because testing multiple choices is necessary to qualify a replacement.  Comparing results of check standards and getting repeatable results over several days is the key to qualifying a new substrate.
Most contract labs and even in-house labs will not have the data on known samples or the time to get these qualifications completed–SORA Labs can help.  Our focus and work with enzyme and probiotic matrixes, day-after-day provide the expertise needed to test your specialty products. Labs usually realize pretty quickly that running these methods sporadically, with a sample or two a week, will not maintain the skill level that these methods require.
When your focus is quality (as it should be), make sure to choose the correct lab for accurate and repeatable results.  When it comes to enzyme and probiotic products, the choice is clear—SORA Labs![/vc_column_text][/vc_column][/vc_row]

There is nothing simple about the process of developing methods for an analytical lab. Using compendial methods from reliable sources like USP, AOAC, FDA, BP, JP, etc. for third-party verification and quality control testing is always your best option. In some cases, however, the ingredient that needs verification does not have a compendial method available. In fact, manufacturers may produce an ingredient and develop a test method specifically for that product. In these situations, a contract lab like SORA Labs, will need to work directly with the supplier to transfer the method to the lab.
Method transfer and development takes time to get up and running, so planning ahead of your product launch is critical. After receiving the method from the ingredient supplier, the lab will attempt the assay. There is usually further discussion and proficiency testing after this first attempt to get accurate and repeatable results. Often, the method that is transferred will only be applicable to the raw material, and it can be challenging to adapt the method to a finished product matrix.
Ingredients like probiotics with CFU/g counts, white kidney bean extract with alpha-amylase inhibition testing and even special gluten-digesting enzymes are examples of ingredients that can be difficult to test once included in a blended matrix. While this testing can be tricky, it’s not impossible for a competent lab. Since test methods for these types of ingredients are designed for the raw materials and simple finished products, there may be additional method development when assaying the ingredients in a complex blend. In some rare instances, the resources and time it takes for method development may be cost-prohibitive to develop the product, so testing during research and development can prevent impossible challenges down the road. A rule of thumb—the simpler the blend, the more straight-forward the testing will be. Understanding the possible challenges up-front will give you a better understanding of the formulation process and what it might take to create your product.
When enzymes and probiotics are in your formulation, SORA Labs wants to be your specialty testing lab of choice. Call us today for a quote!

The demand for finished product testing has been steadily increasing for the past year.  With FDA findings on the rise, marketers and manufacturers are trying to better understand the specific interactions with all the combined ingredients in the final product. Unfortunately, when testing is performed on the finished product only, there may be a scramble to understand the interactions between the active ingredients and choose what markers can be recovered to meet label claims.
The proper way to handle full label claim testing is to perform the appropriate tests during the research and development stage. During this stage, the ingredient interactions can be conclusively determined, so over-formulation or other formulation changes can be made if necessary.  With this data in-hand, the specifications can be set, label claims can be calculated and testing guidelines can be created. When this protocol is followed, the final quality control testing on the finished product becomes the efficacy verification step that it is intended to be.
This type of testing protocol is especially important in probiotic and enzyme formulations, as there are many common interferences that have been seen time and again. The good news is, these can be proven with a quick spike recovery test or small batch lab blend to verify any ingredients that may be causing interference.  A knowledgeable and experienced lab will know exactly how to get you the information you need to ensure a successful product—we are here to help!  Testing will help you fully understand your products, and if you see an unusual result or don’t understand why the result is much higher or lower than specification, then we can help explain it.  We’re here to help you solve the mystery! Just remember, testing your finished product blends is challenging but not impossible with the right partner.

[vc_row][vc_column][vc_column_text css=”.vc_custom_1534182068266{margin-bottom: 0px !important;}”]There are many ways to demonstrate compliance with the Code of Federal Regulations, Prop 65 and other regulatory requirements. However, heavy metal testing is one of the most important and can identify elements that could adulterate the finished product. This testing helps ensure that ingredients used in manufacturing will not contribute to harmful levels of arsenic, cadmium, mercury, lead or other elements. And, it’s not just manufacturers that are on the hook for heavy metal compliance. Even brand owners are responsible for the quality of their finished product and preventing adulteration.  A recent FDA Warning letter highlights the full scope of compliance responsibility:
FDA warning letter to a health food store dated March 9, 2018

• Although a firm may contract out certain dietary supplement manufacturing, packaging, and labeling operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements.

Heavy metals are tested by measuring in low, parts per million levels using sensitive equipment to detect the trace amounts of harmful elements. Ion Coupled Plasma with Mass Spectrometry (ICP-MS) is used most often for this testing. This type of contamination can often be found when plants are grown in soil that contains high levels of these metals. The plants are fed by the soil and may absorb the unwanted elements.  Therefore, all botanical ingredients should be screened to ensure they are free from heavy metal contaminates.
Ingredients that are processed in countries or areas where water quality is a concern will also need to be tested, as tainted water may also lead to heavy metal contamination.  Qualifying each ingredient supplier and testing raw materials is a key component for avoiding adulteration of the finished product.  Although heavy metals are not the only source of adulteration in ingredients, they should be addressed, with specifications set for high-quality finished product. Let SORA Labs help with your heavy metal testing.  Request a quote today![/vc_column_text][/vc_column][/vc_row]

As your partner in quality, we have the fifty-thousand foot view privilege. SORA Labs is known for problem solving and working closely with customers to analyze complex formulations, thousands of test come through our doors. Let’s talk about the most complex ingredient/nutrient formulations that bring analytical challenges with them.
*Enzymes and probiotics are sensitive to heat and humidity. They also come with special handling instructions, and as the weather gets warmer, it’s a good idea to ship samples overnight or in a cooler with ice packs. The goal for testing is to have results that are representative of the material being stored at your facility. If these sensitive materials get too hot they could degrade in shipping, then the test results would not accurately represent your material.
*If it’s not recommended, leave the spec off…it’s OKAY, honestly! When setting required specifications for probiotic products, review monographs from the United States Pharmacopeia (USP)/Food Chemical Codex (FCC) or other compendia for guidance.  You will notice, the probiotic monographs don’t recommend total plate count (TPC)/aerobic plate count (APC) specifications. Instead of listing APC/TPC, labeling recommendations  established by International Probiotic Association (IAP) and Council for Responsible Nutrition (CRN) in a development of scientifically-based “Best Practices Guidelines for Probiotics” recommends labeling guideline specifications to colony forming units (CFU)/gram, which have been included in the FCC.
*Both probiotics and enzymes can have interferences from co-ingredients in the blend.  Another popular sample submission is the food/gummy matrix, which can also create testing challenges. We can help! See our “Challenge Accepted” blog for insights on common interferences.
*Avoiding FDA Warning Letters and 483’s for lack of finished product testing is the brand owner’s/manufacturer’s responsibility. Supplement products are complex and testing interferences in the finished product are common.  These interferences may make it impossible to meet the label claim on the bottle for every ingredient, but testing can prove these interferences. Documentation is the key to a successful FDA inspection.
Just remember, the goal is to procure testing from experienced lab partners that can provide accurate CofA data.  SORA Labs wants to be that partner, providing a seamless extension to your quality control department!