Advancing The Development Of Dietary Supplements And Biologics

By Mike Kuehne, ACSYS, Inc. 

Organizations that consistently develop and launch new products efficiently in an environment of increasing regulatory scrutiny, successfully manage regulatory risk. Organizational regulatory risk management capabilities may become a competitive advantage for all development stages. This report will address the regulatory risk of Biologics and also Dietary Supplement development through a review of regulatory trends from Q1’11 through Q2’12. Longer term trends will be identified as they occur based on additional regulatory findings. The information presented is both across biologics and dietary supplement categories and within each category. A thorough review of all FDA activity in the area of biologics and dietary supplement development and production provides insight into regulatory risks. This information is used to:

• Evaluate and review suppliers (internal and external).
• Develop effective strategies for managing development initiatives.
• Establish improved monitoring programs for manufacturing performance.
• Ensure proper documentation review (design, materials/components, complaints).
• Identify risks associated with manufacturing, distribution and reporting. 

Common elements exist in regulatory activity for biologics and dietary supplements regarding causes of regulatory citations. These commonalities further highlight areas of ongoing risk and provide a means of proactively addressing quality/compliance process gaps.