US FDA guidance looks to stem ‘major problem’ of data integrity

The US Food and Drug Administration (FDA) is hoping to reduce the problem through draft guidance issued last week to help firms ensure data be reliable and accurate.

“FDA has increasingly observed cGMP violations involving data integrity during cGMP inspections,” ​the document​ says. “Ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, and of FDA’s ability to protect the public health.”​

Chinese API maker Zheijang Hisun Pharmaceuticals was hit with a warning last December​, while a number of Indian drugmakers – seven firms between mid-2013 and mid-2014​ - have also been hit due to data integrity problems. Facilities in Italy​ and the Czech Republic​ have also received warnings citing data integrity failings.

The guidance consists of 18 questions and answers to assist drugmakers in ensuring the quality of their data, including how and when to limit access to the computer systems controlling data input.

Drug Shortages​

Justin Neway from science-led processing optimisation firm Dassault Systèmes Biovia agreed data integrity has been a “major problem”​ for industry.

He told delegates at last week’s Bioprocess International European Summit in Vienna, Austria “the failure to prepare written processes mainly in foreign facilities”​ has helped contribute to the growth in warning letters and contributed to drug shortages.

Between 2007 and 2013, 40% of drug shortages were due to quality issues, incorporating data integrity, he said. Another 30% was down to problems with production delays and capacity issues.

The data integrity document follows a number of other guidelines produced to help control quality. Last year​ the FDA released draft guidance offering insight on quality metrics for drugmakers, while in 2013​ the Agency published quality guidance outlining the roles and responsibilities for a third-party manufacturer.