Kayla Pham, vice president of quality at Best Formulations/Sirio Pharma shares why more and more, nutrition and nutraceuticals brand owners are placing pharma-grade quality control atop their manufacturing partnership wish lists.
Sirio Pharma
The nutraceuticals and nutritional products sector has some consumer convincing to do. And that’s an understatement.
Quality control
Per an alarming recent field study whose results were published in JAMA Network Open, a mere 11% of nearly 60 tested supplements provided the amount of key ingredients listed on their labels. The revelation sparked a round of negative press in prominent outlets, including Science News.
Had, say, one in nine – that’s 11% - of the products tested not passed muster, the “just a few bad apples” narrative may have provided adequate cover. But when eight in nine fail, the entire orchard becomes suspect – roots and all. The JAMA findings suggest that, from a quality control standpoint, the entire industry requires reimagining.
And the sooner, the better. Quality control issues can extend well beyond an undesirable yet largely innocuous disconnect between the quantity of key ingredient in a product and the amount listed on its label. And while more serious quality issues such as batch contamination or harmful substances are indeed rare, they also become more top-of-mind to consumers when the industry’s overall reputation is credibly questioned by leading sources like JAMA.
Given the scores of details that comprise comprehensive quality control, the issue can be intimidating – or even insurmountable – to the honest, hard-working nutraceuticals and nutrition companies that, all study results aside, I am convinced comprise the overwhelming majority of brand owners. Quality control is such a gargantuan, multifaceted issue that its challenges are far, far more often explained by a dearth of information or internal capabilities than a lack of good intentions.
Following the rules
The worthiest CDMOs are well advised to take a top-down approach to quality control, with overarching principles and protocols that funnel down throughout the entire organisation.
Unsurprisingly, this concept largely follows the type of good manufacturing practice (GMP) guidelines adhered to in the single most quality-critical industry in the world: pharmaceuticals. By borrowing QA/QC cues from pharma, the most robust nutrition CDMOs can bring together a variety of sweeping quality assurance and quality control activities.
At their best, this means the interconnection of elements such as thorough, brand name-exclusive supplier vetting, expertise-driven formulation development, detailed ingredient shelf-life analyses incorporating high-tech tools like forced degradation stability studies, and production line data collection for actionable metrics that help ensure product efficacy from initial concept through full-fledged commercialisation. Meanwhile, sophisticated inspection and in-process testing equipment, optimised facility floorplans, and system-wide unit-level traceability capabilities – not only for finished products but also their key ingredients – can provide levels of transparency and process oversight that, increasingly, are highly desirable to nutrition brand owners.
Granted, not all CDMOs can meet the quality-centric moment, since such an elevated approach to QA/QC comprises an intelligent, integrated mix of manpower and machinery. Experienced quality management professionals must provide strong, steady support for front-end research and development, ensuring that manufacturing processes are spot-on from inception. Further downstream, intricate and intertwined inspection capabilities should include modern laboratories and state-of-the-art instruments and equipment.
Conclusion
The goal is to grow more exacting and therefore reassuring over time. Sirio Pharma has recently procured both Liquid Chromatography Mass Spectrometry LC-MS and Gas Chromatography-mass spectrometry (GC-MS) systems for contaminant testing. These tools broaden and deepen our QA/QC capabilities, from detecting foreign particles to identifying pesticide residues – an ongoing industry-wide concern. Sophisticated tools such as these align with a progress-oriented mindset, one that continuously raises standards and provides greater precision and reassurance over time.
In an industry facing justified scrutiny, nutrition brands that embrace pharma-grade quality control – whether by building in-house expertise or partnering with CDMOs that already have it – will not only protect their consumers, but also differentiate themselves in a crowded marketplace. The winners will be those who view quality not as a regulatory hurdle, but as the surest path to trust, longevity, and growth.