New synthesized data shows that total warning letters continued to climb in 2017.[NEVER MISS A WARNING LETTER: Start your 30 day free trial of the GMP Regulatory Intelligence Newsletter.]
Outside the US
Of course, this is part of the on-going trend of increased international inspection activity as the FDA “catches up” with the reality that 80% of all active pharmaceutical ingredients (APIs) for the US market is manufactured in either India or China. Can China learn from India?
China, India, and Europe accounted for almost 80% of drug GMP warning letters issued outside the US over the last five years.
Data integrity is the BIG ISSUE for these warning letters, and not just for foreign sites anymore. The US has essentially “caught up” (in a bad way).
Predictions for 2018
Based on the numbers shown in the below infographic, here’s what to expect for 2018:
- There will be continued OUS focus where most generic drugs and APIs are made.
- The FDA will continue doing a balancing act between enforcement actions and drug shortages.
- There will be a continued increase, both US and OUS, of failures in the area of data integrity — including falsifying information on the Certificates of Analysis that obscure or hide key components in the supply chain.
- The continued focus on OTC manufactures that began in 2017 will continue.
- There will be a continued focus on contract manufacturers, laboratories, and their clients.
- Additional firms will be cited for failures in process validation and, more specifically, for failing to conduct ongoing process monitoring.
- Intervals between inspections and warning letters will continue to decrease particularly when outsourcing facilities and compounding pharmacy data are excluded.
This data has been released as part of a new infographic about FDA Warning Letters that you can see below.
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