What can be put in place or done to limit these occurrences

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Reference no: EM133432776

Question: 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? What can be put in place or done to limit these occurrences (ex. quality agreements)? Are further amendments and updates to guidances or even ICH standards necessary (ex. ICH Q7 Documentation and Records)?

Reference no: EM133432776

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