Faced with challenges involving quality compliance, the Indian Pharmaceutical Alliance (IPA) in collaboration along with McKinsey & Company has devised guidelines on data reliability.
The move by the pharma industry body is to help improve quality systems to Indian drug companies, which have been under scanner with regard to quality compliance norms of global regulators.
Released on Thursday at the second edition of IPA’s quality excellence conference, India Pharmaceutical Forum 2017 in Mumbai, these guidelines are available on the IPA website for public opinion.
The guidelines contain six elements critical for data reliability such as technology systems, process design, risk management, governance, culture and capability.
Data reliability or data integrity has always been one of the crucial aspects of quality compliance at pharma companies.
The drug makers have even faced the ire of drug regulators for lapses 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.