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