Abstract
DATA INTEGRITY: AN OBLIGATORY TOOL TO SURVIVE PHARMA INDUSTRY

Sunita Sunil Gagare*, Sunil Krushna Gagare and Dr. Ashish Suresh Jain

ABSTRACT

Medicines and health products are important for addressing health problems and improve quality of lives. They form an indispensable component of health systems in the prevention, diagnosis and treatment of disease and in alleviating disability and functional deficiency. All regulatory bodies (e.g. USFDA, WHO, MHRA) are supporting countries in ensuring equitable access to essential medicines and other health products that are safe, effective and of assured quality. For assured quality the manufacturing should be carried out according to cGMP. The regulatory bodies regularly practice audits and inspections to know cGMP followed or not by respective industries. The assurance is done by auditing data retained by respective industries. Therefore data retained must be integrated.

Keywords: cGMP, ALCOA, data integrity, warning letters.


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