Barbara Unger:
I see four trends in drug GMP enforcement actions over the past couple of years and all reinforce FDA’s focus on patient safety and public health.
- The most visible trend for fiscal year 2014 warning letter enforcement actions was the focus on compounding pharmacies. These businesses received the majority of GMP warning letters issued to drug manufacturers. The events in 2012 where compounded products from the New England Compounding Center were reported to have resulted in deaths and long term injury due to fungal meningitis seems to have been the most recent impetus for these actions. The Drug Quality and Security Act that became law in November, 2013 clarified FDA’s authority over these businesses.
- The number of warning letters issued to sites outside of the US continues to increase as FDA expands their inspections to reflect the global nature of drug production and supply chain components. In their planning for FY 2015, the total number of drug GMP inspections OUS is anticipated to exceed the number conducted within the US. FDA is taking action on a global basis rather than focusing only on domestic sites.
- Recalls citing the presence of foreign particles in injectable products has increased over the past 3 years. Often, this is reported to be based on a single customer complaint. The foreign particulates can be plastic/latex/glass that are intrinsic to the manufacturing process or mold, hair and insect parts that suggest a failure in GMP control. Most of these recalls are Class I.
- FDA continues to focus on data integrity assessments during both domestic and foreign inspections. Problems are identified with electronic systems and records and paper records. While data integrity assessments initially focused on GMP manufacturers, problems have also been identified at GCP and GLP providers. In addition, other regulatory authorities including the EMA inspectorate and the World Health Organization (WHO) inspectors are now citing deficiencies in this area.