EY India data integrity survey flags gaps, missing processes
This article was originally published in Scrip
An EY (formerly Ernst & Young) survey around data integrity compliance issues within the Indian pharmaceutical sector has thrown up some potentially worrisome findings, including an absence of quality processes and procedures at some firms amid work pressure and manpower shortages.
The survey, which covers more than 170 respondents from the pharmaceutical industry in India during January-March 2015, found that 33% of the respondents did not conduct reviews to assess potential gaps in assurance of data integrity. In addition, 13% of the respondents did not have clearly documented standard operating procedures (SOPs) on backup and deletion of laboratory data files generated by high performance liquid chromatography (HPLC) and gas chromatography (GCs).
It also noted that 33% mentioned having shared employee login IDs and passwords for laboratory systems such as HPLC and GCs while 25% were unaware of the 21 Code Federal Regulation (CFR) Part 11 standards prescribed by the US FDA that establishes the criteria to record data in electronic form.
Significantly, 21% stated that audit trails on laboratory equipment were not always enabled in their organizations. EY noted that an absence of audit trails can be a serious problem since there would be no records of data capture, which could lead to "severe" action by regulators.
"Maintaining data integrity is crucial for the pharmaceutical sector. Today, companies with existing or anticipated concerns around data integrity should initiate regular proactive data integrity assessments. These periodic assessments provide assurance to all stakeholders involved – such as customers, investors and regulators, as well as reaffirm the management's commitment toward highest standards of quality," Rajiv Joshi, partner, fraud investigation and dispute services, EY, said.
A number of Indian firms including Sun Pharma, Ranbaxy (now part of Sun), Ipca and Wockhardt have, over the recent past, been pulled up by the FDA for good manufacturing practice (GMP) deviations at their sites, some of them over data integrity lapses.
Not homogenous
Industry experts were measured in their response to the survey's findings but underscored that it may be unfair to paint all Indian firms with the same brush.
Dilip Shah, secretary general of the Indian Pharmaceutical Alliance (IPA), which represents leading domestic firms, told Scrip that the Indian industry is "not homogenous" and some are still "beginners" and still "learning."
"So, we are not surprised that the overall results show such trends," he said.
Mr Shah also referred to a quality forum initiated by the IPA, which has the leading consultancy McKinsey & Co as the "facilitator." The forum expects to work towards institutionalizing quality metrics and benchmarks to quantify performance improvement of the industry. Among others, the forum also expects to monitor and "shepherd" a fundamental quality culture and transformation in the industry.
"India should be the benchmark," Mr Shah added.
Other experts told Scrip that the EY survey perhaps ought to have defined/stratified its respondents such as on the basis of their export sales to better understand its overall implications or which strata needs urgent attention. The survey's principal respondents are senior executives from the business management, quality, and legal and compliance domains. They represented a mix of active pharmaceutical ingredients, formulations excipients and other firms supplying domestically as well as exporting to countries such as the US, Europe, Japan and Australia.
Work pressure
The survey also suggests that while 87% respondents "signed off" their understanding and compliance with good manufacturing practice (GMP) norms, 30% still claimed to have received inspection observations from a regulatory body over the last three years, raising questions on the effective implementation of GMP norms.
There are also signs of significant work pressure. The survey noted that more than 57% of employees had "seen" work pressure on manufacturing personnel to meet key performance indicators such as volume of output, low rejection ratio and overall equipment effectiveness. It also suggested that 18% did not have adequately staffed quality assurance teams to review the manufacturing and testing of all the products independently.
Both work pressure and a manpower crunch could potentially heighten the risk of inaccurate or incomplete documentation and eventually impact product quality.
The survey also notes that setting up whistle-blowing frameworks in India appeared to be still a work in progress.
While 47% of the respondents indicated that whistleblowing policies and mechanisms had been implemented internally, 28% suggested that their organizations did not have such frameworks in place. An absence of a whistle-blowing policy meant that individuals who may want to help their organizations by flagging any unethical acts or wrongdoings may be forced to report such issues externally, EY cautioned.