[GMP Update] Documents Required for MDSAP-Based Review.

MFDS advised that the review body's own inspection records may be omitted because they fall outside the scope of review using MDSAP audit results.

A separate letter from the manufacturer explaining that the omitted records cannot be submitted is also unnecessary.

Contact BCG for further information.

https://emedi.mfds.go.kr/gmp/aply/view/MNU20284?&pstSno=15&bbsSno=1339