Removing Compliance Risk For Pharmaceutical Development And Manufacturing

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 pharmaceutical development and manufacturing through a review of regulatory trends during the period from Q1, 2011 through Q2, 2012. The information presented is focused on pharmaceutical development and production. A thorough review of all FDA activity in the area of pharmaceutical 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 pharmaceutical development initiatives.
• Establish improved monitoring programs for manufacturing performance.
• Ensure proper documentation review (batch records, materials/components, complaints).
• Identify risks associated with laboratory testing and data analysis.

Regulatory trends highlight areas of concern for pharmaceutical manufacturers and provide valuable information to prioritize initiatives, implement training and develop metrics to proactively monitor critical business functions. For the period from Q1, 2011 through Q2, 201 the highest level of regulatory activity was centered on Current Good Manufacturing Practices (cGMP) followed by Packaging and Clinical Research. A majority of packaging observations were related to misbranded products whose labels, claims and website do not correspond to information held by the FDA from submissions. Review of Figure 1 indicates a clear regulatory priority for cGMP’s.