Experts Suggest Whistleblower Hotlines For Reporting Data Integrity Problems
This article was originally published in The Pink Sheet Daily
Pharmaceutical manufacturers need to have whistleblower hotlines in place where employees can anonymously report data integrity problems without fear of reprisal.
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The Justice Department is imposing harsh penalties on manufacturers that commit serious GMP violations and this trend will continue in the foreseeable future. DOJ is also getting more calls from FDA and whistleblowers alleging GMP violations under the False Claims Act.
The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.
The US FDA managed to issue 94 drug GMP warning letters last year despite the pandemic, with fewer expected for 2021. Top issue areas included lack of sterility assurance, nitrosamine impurities, poor data integrity and basic GMP failures.