Ara Testing Labs has been receiving questions recently about regulatory expectations and when stability studies are needed. This article shares insight that will help you understand both topics on a deeper level. Much of the confusion comes from how expiration dates, “best‑by” dates, and manufacture dates are interpreted. The Importance of the Expiration or “Best By” Date The key point … Read More
From High Risk to High Quality: Testing and Supplier Qualification
The feedback on these blogs and podcasts has been wonderful! I genuinely appreciate all the Regulatory, Quality, Management, and R&D teams out there who work together every day to set specifications, qualify vendors, write SOPs, determine test methods, and collaborate with third‑party labs like ours. It takes every one of us, working as one team, to manufacture high‑quality supplement products. … Read More
Building Quality from the Start: Setting Specifications for Compliance
Setting Specifications: Why It Matters Setting specifications for raw materials and finished goods is one of the most important steps in protecting your business. FDA 21 CFR Part 111 requires manufacturers to establish specifications for identity, purity, strength, and composition for every component and finished product. Too often, manufacturers focus on production and brand holders focus on marketing, leaving the … Read More
The Push and Pull of Manufacturing vs. Quality in the Supplement Industry
In today’s supplement manufacturing environment, there is a natural tension: the pressing priority of getting products ready and shipped quickly and the responsibility of making sure they meet the required standards for consumer safety and regulatory compliance. Manufacturing vs. Quality Process Manufacturing teams are driven by schedules, while Quality teams follow FDA GMP 21 CFR Part 111 regulations to ensure … Read More
Start with the End in Mind
Why Testing Methods Matter In supplement manufacturing, FDA 21 CFR Part 111 (Current Good Manufacturing Practice for Dietary Supplements) and 117 (Preventative Controls for Human Food) set the foundation for quality products. One key requirement is using scientifically valid test methods. If your finished product cannot be tested using a UV-Vis method because of co-ingredient interference, then your raw materials … Read More
Let’s Build Your Product’s FDA Compliance Story
At Ara Testing Labs, we get a lot of questions about blended supplement products and testing requirements. Many manufacturers are told they don’t need to test blends because of recovery issues. In some cases, labs struggle with how to approach these products at all. From a Food and Drug Administration (FDA) compliance standpoint, our position is clear and simple: you … Read More
Why Allergen Testing Matters
Did you know that 33 million Americans, according to FARE (Food Allergy Research & Education), have food allergies? As such a prevalent issue and safety risk, food allergens in supplements are ideally detected at the manufacturers level before products meet the consumer. Otherwise, it could be too late. Food allergens are a serious concern for both consumers and manufacturers. With … Read More
We are ready to start receiving your samples!
Getting Ara to this point has been a lightning-fast process, as we began building our lab in April and received our ISO 17025 accreditation in December. Now that we’re moving full speed ahead, we’re excited to start receiving your samples. To get started, you must first have the lab qualified, per good manufacturing practices. We’ve made this process easy by … Read More
Reliable, Repeatable Testing Methods Matter
With limited standardized test methods, ingredient manufacturers often develop their own. However, these methods must align with industry standards to ensure reliability and consistency. Testing should be based on established compendia to maintain uniformity and accuracy. But what happens when no established compendial method exists? Standardizing Success: Why Method Alignment Matters To optimize testing protocols, manufacturers invest in extensive R&D, … Read More
The Wild, Wild West of Probiotic Testing
Probiotics often feel like the Wild West—with numerous testing methods being used and each manufacturer advocating for their own standards. When it all feels a little uncertain, you want to be sure that your testing lab is ensuring accurate testing and has the expertise to troubleshoot if unexpected issues arise during testing. Preventing Avoidable Issues As your partner through every … Read More
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