AHPA President Michael McGuffin on Tuesday provided an overview of supplement regulations and compliance strategies at the Best Practices in QC, GMP for Dietary Supplements and Nutraceuticals Effective Compliance Seminar in Salt Lake City.
McGuffin's presentation covered a wide-range of supplement regulatory issues from current good manufacturing practice (cGMP) requirements and Food and Drug Administration (FDA) inspections to responses to FDA inspections and FDA warning letters.
"The essence of cGMP is a production and process control system that is designed to ensure the quality of the dietary supplement," McGuffin said. "It is important to ensure the quality of the dietary supplement throughout the production and process control system. Quality cannot be tested into the product only at the end."
McGuffin reviewed the FDA inspection process and highlighted common observations that FDA officials include in warning letters. He also provided some advice on responding to FDA inspections.
"Responses to FDA observations should be detailed and provide evidence of implementation," McGuffin said. "It should explain the procedure developed to address FDA's observation and provide evidence that the procedure is in effect and being followed."
McGuffin also stressed the importance of using FDA warning letters to learn about the issues that FDA looks for when inspecting a facility for cGMP compliance. He used examples from recent warning letters to highlight common issues that FDA observes during inspections.
The compliance seminar provided attendees with practical approaches for quality control and cGMP compliance for dietary supplements, nutraceuticals, and natural products.
Slides from McGuffin's presentation are available online.