Probiotic enumeration isn’t a one‑size‑fits‑all test. Each strain grows best on specific agars, co-ingredients can introduce interference, and method selection takes research, especially with blends. At Ara Testing Labs, our team uses compendial and industry methods, strain‑specific workflows, and hands‑on troubleshooting to ensure accurate, sound CFU results. Why Probiotic Testing is So Complex Probiotics are some of the most scientifically … Read More
Inside Ara Testing Labs
Key Updates to USP Chapters <2021> and <2022> What You Need to Know for April 2026 The United States Pharmacopeia (USP) has updated microbial testing standards for dietary supplements to improve accuracy and efficiency. Key changes include: Extended APC incubation: Aerobic Plate Count (APC) is now 72 hours to better capture slower-growing yeast and mold New positive controls: Added to … Read More
Understanding Stability Studies for Dietary Supplements
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
Every Brand’s Path Is Unique
Supplement Brand Responsibility: GMP Compliance Starts With You Outsourcing manufacturing doesn’t mean outsourcing responsibility. Under 21 CFR Part 111, the brand owner is ultimately responsible for ensuring that dietary supplements meet FDA requirements for identity, purity, strength, and composition.1 Vendor Qualification Is Not Optional You must qualify your contract manufacturer and suppliers—you cannot rely solely on their Certificate of Analysis (COA). … Read More
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