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The Indian Pharmaceutical Alliance (IPA) questions the reliance on the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) in the Ohio State University report titled, Are All Generic Drugs Created Equal? An Empirical Analysis of Generic Drug Manufacturing Location and Serious Drug Adverse Events.
Fundamental requirements of GMP compliant software The critical objectives for developing a quality management software application are to make the quality concern investigations processes faster, more reliable, accurate, secure, and permanent for future reference.
. – Process monitoring: regular monitoring and analyzing data related to the manufacturingprocess, such as production rates, quality metrics, and environmental factors, to identify trends or potential issues and take action as needed. What is corrective and preventive action plan?
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