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
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
Introducing Ara and Friends Podcast
We are excited to introduce Ara & Friends, a podcast dedicated to exploring dietary supplement testing, quality, and regulatory standards. Our discussions will dive into the industry’s best practices, challenges, and insights—starting with probiotics. For our first episode, we’ll explore a reference in the CRN’s guidelines for Probiotic Best Practices. In partnership with the International Probiotic Association (IPA), the Council … 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
Handling Out-of-Specification (OOS) Results: A Team Approach
We are ready to work with you, and we’re excited to say that it’s now easier than ever! To simplify the process of qualifying our lab, we’ve provided some helpful tools. In our qualification tools, we have included a self-audit of our lab. Qualification Tools How We Handle OOS Results A common audit question we get asked is how we … Read More