Growing Cooperation Between FDA and EMA Highlighted in Recent Ben Venue Inspections

The mutual focus of FDA and EMA on aseptic processing compliance at Ben Venue’s Bedford, Ohio plant – which has resulted in an EMA recommendation to recall three oncology drugs contract-manufactured by Ben Venue and the firm’s decision to cease operations at the facility while the issues raised are being addressed – illustrates the increasing level of cooperation among international agencies in the GMP arena.

The sharing of and reliance on inspection information between agencies is becoming the norm as drug authorities worldwide wrestle with pitting their limited resources against the daunting challenges of regulating global supply chains (IPQ “In the News” September 7, 2011).

Ben Venue’s recent compliance problems began with a joint inspection by UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the French health authority AFSSAPS in March, 2011, that led to restriction in the importation of some medicines into the EU manufactured at the Bedford site.

In May 2011, two months after the EMA visit, a three-week FDA inspection of Ben Venue’s Ohio facility resulted in a 33-page, 48-item 483 that highlighted a variety of problems in its sterile contract manufacturing operations, including investigation into the root causes of particulate and microbial contamination and issues with aseptic design, monitoring and controls.

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