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The Data Integrity

Ensuring Product Quality and Patient safety

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Data Integrity is a fundamental element of a (Bio) pharmaceutical industry to ensure quality and safety of drugs. It’s a major global concern of health authorities and (Bio) Pharma companies. Although Data Integrity is not a new issue, it has gain alarming attention in last few years due to FDA’s and MHRA’s scrutiny and a number product detention, import alerts, suspension of marketing authorization and warning letter issued to companies found non-compliant.

Although Data integrity is a global issue it is a burning topic in Asia- Pacific, specifically China and India. According to Indian ministry, India has the second-largest number of manufacturing facilities outside of the US (523 as of March 2014) registered with the US FDA. Furthermore, India’s drug exports to the US have risen from US$1.25 billion in FY10 to US$3.45 billion in FY14.2. With the growing importance of the Indian pharmaceutical industry in the global market, the number of foreign regulatory inspections has also increased considerably.



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