An MDSAP certificate obtained through a physical audit to the site can be used for KGMP certification if the following conditions are met:
This applies only to the first KGMP certification.
Only the MDSAP audit report issued in the F0019.1 format is accepted. (Reports issued in formats generated by the Auditing Organization (AO) are not accepted.)
In Section 12 of the MDSAP report, the number of non-conformities of Grade 5 must be zero, or the number of non-conformities of Grade 4 must be one or fewer.
The validity period of the KGMP certificate issued based on the MDSAP certificate will be the same as that of the MDSAP certificate.
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