IGMPI India

During the year 2014, USFDA issued warning letters to Indian pharmaceutical companies on data integrity issues. In the Warning Letters, FDA defined that pharma consultants should be data integrity experts to identify employees at the site, procedures and behaviour of the management which contributed to cause of GMP deviations while handling electronic data. In some of the Warning Letters issued in 2014 serious deviations with regard to the handling of electronic data like data manipulation are listed. Most of the Warning Letters issued by US FDA indicated failure by industry to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards as per 21 CFR 211.194(a). USFDA has been noticing that especially with Indian companies, it did not rely on their capability to resolve the data integrity problems without external support. Now USFDA expects Indian pharma to seek the expertise of third party auditors and consultants to resolve data integrity issues and ensure total compliance.

The Warning Letters issued by USFDA have the following statements reflecting the need to resolve data integrity issues:

1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).


2. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).


3. Your firm frequently performs “unofficial testing� of samples, disregards the results, and reports results from additional tests.


4. The inspection revealed your firm’s use of scratch paper containing critical manufacturing data. The data on these scratch paper records did not always match the data on the corresponding official batch records.