Meeting ICH GMP standards means being compliant with FDA's expectations and therefore enabling production of high quality medicines and/or devices and ensuring patient safety. In recent years the number of incompliances in terms of data integrity (deletion, falsification, record keeping), out of specification results, and more basic GMP issues (cleaning, equipment maintenance, sanitation) has led to an increase in warning letters. Why is this?

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DLDOBAGGINS2013 DLDOBAGGINS2013

08-06-2024
Social Studies

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Meeting ICH GMP standards means being compliant with FDA's expectations and therefore enabling production of high quality medicines and/or devices and ensuring patient safety. In recent years the number of incompliances in terms of data integrity (deletion, falsification, record keeping), out of specification results, and more basic GMP issues (cleaning, equipment maintenance, sanitation) has led to an increase in warning letters. Why is this?

Sagot :

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