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Regulatory Focus™ > News Articles > 9 > Data Integrity a Top Concern for Manufacturers, FDA Says

Data Integrity a Top Concern for Manufacturers, FDA Says

Posted 18 September 2018 | By Zachary Brennan 

Data Integrity a Top Concern for Manufacturers, FDA Says

When a pharmaceutical or active pharmaceutical ingredient manufacturer has data integrity issues, that’s likely the tip of the iceberg, Sarah Barkow, of FDA’s Office of Manufacturing Quality, told attendees of the Pharma and Biopharma Outsourcing Association’s annual conference in Rockville, MD.

“You need to worry about [data integrity] from all levels of the supply chain,” she said. “Once there are data integrity lapses, you know there are other things you don’t know.”

In terms of remediation, she said companies need to follow three steps: conduct a comprehensive investigation, perform risk assessments and form a remediation and management strategy that includes a corrective action plan.

The comments follow a series of warning letters and Form 483s issued by the agency that detail numerous data integrity violations, such as manipulating out-of-specification data or re-running certain tests until favorable results were achieved.

Barkow further explained how when a company receives a 90-day classification letter with an official action indicated (OAI), the first of which FDA began sending in December 2017, a warning letter is to be expected.  And in terms of warning letters, these are the top three concerns Barkow noted:


Ying Zhang, branch chief of FDA’s Office of Process and Facilities, meanwhile explained a new review approach that integrates the process and facility assessment and is meant to reduce a lot of information requests and comments.


And among the common issues or deficiencies in pre-approval inspections, Zhang pointed to a lack of detailed information regarding operations or tests to be conducted at each facility, a facility that’s not performing a function listed in an application or unaware it’s referenced in an application, or even a facility that is no longer in commercial operation.

“I’ve seen two applications submitted recently where companies said their facility wouldn’t be ready for an inspection yet and they received a refuse to file,” she noted.

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