[GMP Update] Cleanroom Entry/Exit Procedures in Document Review (September 2023).

Sites with cleanrooms must submit documents covering clean zones, cleanliness levels, entry/exit, personnel and material flows, and operation and maintenance.

For document review, MFDS advised assessing clean zones, cleanliness levels and cleanroom operation/management procedures, excluding personnel/material flows and entry/exit procedures from this review scope.

Under the revised notice effective 13 November 2023, finished-product testing, monitoring/measuring equipment and sterilisation validation procedures may be checked at a higher procedural level for document review.

Contact BCG for further information.

https://emedi.mfds.go.kr/gmp/aply/view/MNU20284?searchType=ALL&pageNum=3&&pstSno=2&bbsSno=1340