U.S. and UK Cite Data Integrity as Compliance Issue on the Rise

August 21, 2015

Regulators from the U.S. and UK are pointing to data integrity as a compliance issue on the rise lately.

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 June 3 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 sitting in on audits of each EU member state regulatory agency, and the EU will audit the FDA in August.

The FDA found data integrity deficiencies to be at the heart of global compliance issues in fiscal 2014, said Cynthia Schneder, director of CDER’s Office of Compliance. She told the DIA annual meeting June 17 that the agency issued 19 foreign warning letters, and placed eight of those firms on import alerts. Roughly 11 of them were cited for data integrity issues.

Examples included retesting raw materials and API after they had failed, and no corrective and preventive actions were initiated. In one firm, investigators found partially labeled vials dumped in the drain and partially destroyed GMP quality assurance records in the trash.

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