The US FDA has re-emphasized the serious deviations it observed during inspection made in Indian pharma companies. The regulator 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 it expects Indian pharma to seek the expertise of third party auditors and consultants to resolve data integrity issues and ensure total compliance.

“For the third party auditor, the task is similar to detective work which is both demanding and not pleasant. The auditors and consultants are also apprehensive on the kind of support they would get from the concerned company. However, this detective is essential in the interests of patient safety, noted US FDA.

A series of workshops were held in India in the past to educate pharma professionals on the indispensability of compliances to keep warning letters at bay.

Quoting a February 2014 Warning Letter, US FDA said that good manufacturing practice (GMP) deviations detected during inspections related to electronic data submissions was elementary and urgently recommended companies to get a third party auditor or pharma consultant. These experts could first perform an in-depth GMP review and ensure data integrity deficits are removed.

 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). It also pressed for authorized personnel to institute changes in master production and control records, as per 21 CFR 211.68(b). Further, companies were found to perform unofficial sample and disregarded the results, but reported outcomes from additional tests. The inspection revealed companies used scratch paper containing critical manufacturing data which did not tally with that of the corresponding official batch records.

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. Efforts to touch base with employees who left the company before, during, these time periods should also be undertaken accordingly.

Further, the third party auditors or consultants needed to identify GMP non-compliance, reveal the identity of managers in charge and to what extent the top and middle management knew about data manipulation. Internal reviews need to be extended to other sites which are known to be involved in violations of GMP-compliance, pointed out US FDA.

According to Kaushik Desai, pharma consultant and Hon. Secretary Indian Pharmaceutical Association (IPA), Indian pharma companies need to take cognizance of the issues by clearly understanding the US FDA expectations from consultants involved to help out data integrity issues. The regulator has also been conducting several workshops and now IPA is also open for collaboration with US FDA to conduct extensive training  going by its exposure and experience it has with professionals working in companies in the country.