News about GMP/cGMP

29.04.2016

Data Integrity: Once Again the Hot Topic

Another Indian drug maker received a warning letter issued by the US FDA. Once more the hot topic is data integrity – a common feature nowadays.

One year after the inspection the warning letter now send to Hyderabad-based Sri Krishna Pharmaceuticals notes repeated violations:

  • Deleted sample data by a quality control person
  • Data manipulation due to a lack of computer controls
  • A lack of data audit trails,

just to name a few.

Shortly after publishing the Draft Guidance on Data Integrity for GMP Compliance, the findings in the warning letter violate almost every single recommendation therein. Sri Krishna Pharmaceuticals is only one company in a long list of Indian pharmaceutical manufacturers that received a 483 by the US FDA. Imports of products from Sri Krishna have been banned from entering the US since August 2015 due to cGMP-violations and this is not supposed to change in the near future.

The FDA is taking the issue of data integrity even one step further. Clinical and bioanalytical studies conducted by the India-based contract research organization Semler Research are not acceptable, again due to data integrity concerns. Sponsors of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) were already informed that those studies have to be repeated using a company other than Semler.

“The inspection found significant instances of misconduct and violations of federal regulations, including the substitution and manipulation of study subject samples,” FDA says. An “Untitled Letter” detailing with the findings has been sent to Semler already.


Source:

FDA: Drug Safety and Availability

FDA: Letter to NDAs and ANDAs

 



Comments

No comment has yet been written about this news


Write your comment about this news