Pharma industry body proposes guidelines on data reliability
The guidelines address six elements critical for data reliability such as technology systems, process design, risk management, governance, culture and capability, according to Vikas Bhadoria, senior partner at McKinsey & Company
The Indian Pharmaceutical Alliance (IPA), an industry
lobby group, along with knowledge partner McKinsey & Company has devised
guidelines on data reliability as part of its efforts to help improve quality
systems at a time when domestic drug makers are facing challenges in dealing
with the evolving quality compliance norms of global regulators.
The guidelines address six elements critical
for data reliability such as technology systems, process design, risk
management, governance, culture and capability, said Vikas Bhadoria, senior partner at McKinsey & Company.
The data reliability guidelines were released
on Thursday at the second edition of IPA’s quality excellence conference, India
Pharmaceutical Forum 2017, in Mumbai.
The guidelines are available on the website
of IPA for public.
Data reliability or
data integrity is one of the crucial aspects of quality compliance at pharma
companies and drug regulators pull up manufacturers for any lapses found in
maintaining and disseminating data.
Of the 19 quality-related warning letters
issued by the US Food and Drug Administration (FDA) globally in 2014, 10 had
data reliability issue and in 2015 (up to August), nine out of 10 warning
letters cited data reliability concerns, according to details on IPA’s website.
Over the last few years, Indian pharma
companies, including leading firms like Sun Pharmaceutical Industries Ltd and
Dr. Reddy’s Laboratories Ltd, have come under the glare of the US FDA due to
breaches of manufacturing norms at their plants.
Other drug makers like Lupin Ltd, Cadila
Healthcare Ltd, Cipla Ltd, Wockhardt Ltd, Ipca Laboratories Ltd and Aurobindo
Pharma Ltd also faced regulatory issues.
The IPA formed a Quality Forum in March 2015
to identify and focus on key areas for improvement in quality.
In 2016, the group focused on developing data
reliability guidelines, standardize quality metrics and collate best practices
for investigations and process validation, and developing technical training
modules and assisting companies to build quality culture. So far, the Quality
Forum has spent Rs15 crore on various activities.
While continuing on last year’s activities,
the group will focus on areas of batch failure investigations, market complaint
investigations, and good documentation practices in the current year, D.G.
Shah, secretary general of IPA, said adding that guidelines to investigate
batch failures are also planned.
Shah also emphasized on the need to
rationalize standard operating procedures by simplifying them and doing away
with some redundant processes.
India has 573 US FDA-approved manufacturing
sites—the highest outside the US—and the number of warning letters from US FDA
to Indian plants has increased in the last five-six years.
During 2011-15, India accounted for 30% of
102 warning letters issued globally.
The number of inspections conducted by the US
regulator has also increased.
As per data on IPA website, the US FDA
conducted an estimated 135 inspections in India, accounting for 11% of global
inspections. This is higher than the average of 102 inspections carried out
between 2011 and 2014.
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