IPEC e-newsletter - Excipients Insight March 2017 - 31-03-17


Inside this issue


Data integrity citations loom large in FDA warning letters

An analysis of warning letters issued by the US Food and Drug Administration (FDA) for Good Manufacturing Practice (GMP) violations in fiscal 2016 has revealed that 80 per cent cited deficiencies in data integrity.

The analysis by Barbara Unger of Unger Consulting – published by PharmaceuticalOnline.com - notes that the percent of warning letters that cite deficiencies in data integrity for ex-US sites is now reached about the same level as US sites, with the increase in the latter representing a "significant increase" on previous years.

There were 46 warning letters citing data integrity sent in FY2016, with 8 of 11 (73 per cent) issued for US sites and 29 of 35 (81 per cent) for overseas sites. "FDA continues to refine the requirements for data integrity remediation that they include in warning letters with the most egregious deficiencies," writes Unger, pointing to one good example.

"Firms should monitor publicly available health authority enforcement actions and trends as part of a comprehensive GMP intelligence program, because FDA expects firms to monitor these actions and to correct similar deficiencies at their site(s)," she adds.

Data integrity in the context of pharma manufacturing has led to a rising number of regulatory enforcement actions citing failures in the recording and review of manufacturing data, including not only warning letters but also bans on imports from some manufacturing facilities.

A comprehensive body of information on data integrity can be found in a library set up by supply chain security body Rx-360 here.




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