Data Integrity Issues Cause Uptick in Critical Inspection Findings, UK Official Says

The number of critical deficiencies at pharma facilities registered in the UK nearly doubled from 2012 to 2013, spurred mainly by problems with data integrity, regulators say.

Problems with documentation of procedures and manufacturing accounted for 5.3 percent of all critical and major defect areas reported in inspections, according to data from the Medicines and Healthcare products Regulatory Agency.

The rise in critical deficiencies — from 0.07 per inspection to 0.13 — comes as the number of less serious, but still major deficiencies dropped to 1.87, from 2.27 in 2009. Critical deficiencies are those serious enough to warrant regulatory action, while major deficiencies are not unusual in an inspection.

Of the top 10 issues cited in critical and major inspection findings, only two — contamination and design and maintenance — relate to physical facilities, said Gerald Heddell, head of the MHRA’s Inspection Enforcement and Standards Division. The rest — investigation of anomalies, quality management, CAPA issues, supplier and contractor audits, change control, documentation of manufacturing and procedures, training, and finished product testing — relate to dealing with problems.

Heddell, who spoke at the ISPE/FDA/PQRI Quality Manufacturing Conference in Washington, D.C., said the MHRA is working with the FDA to increase mutual reliance between Europe and the U.S. FDA officials are currently sitting in on audits of each EU member state regulatory agency, and the EU will audit the FDA in August. Authorities on both sides are looking at how GMPs align and the kinds of data that needs to be shared.

Everything is moving toward mutual reliance, Heddell said, adding the MHRA would welcome having to inspect U.S. facilities less often than it currently does.

Tom Cosgrove, director of the FDA’s Office of Manufacturing Quality within the Office of Compliance, confirmed that the agency has the legal authority to move toward more systematic reliance and that it will do so once every EU country is comfortable and ready.

Last week, CDER Director Janet Woodcock told conference-goers that the FDA is moving rapidly to establish a mutual inspection program with similar GMPs and quality metrics. — Kellen Owings