Utilize MDSAP certificate for KGMP certification

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.