Manufacturers and marketers remain ultimately responsible for the authenticity and safety of their company’s supplements. Product integrity is ensured when a company successfully implements a quality management system that meets FDA’s expectations in 21 CFR part 111 for compliance. with current good manufacturing practice (cGMP) standards. To vouch for product quality and remain consistently competitive without worries of shutdowns or recalls, companies should be strategic and intentional to be “audit prepared” at all times. Under these conditions, visits from regulatory bodies such as FDA—planned or unplanned—can then be viewed as an opportunity to showcase a high caliber.
Routinely following quality-by-design…
