[GMP Update] Signature Requirements for Submitted Documents (September 2023).

MFDS stated that signatures or seals from the quality manager were not required on documents other than the quality manual. Applicants had requested a single replacement declaration, corresponding to the former site preparation certificate removed by the GMP amendment, instead of signatures on each document.

Applicant-prepared site summaries, facility information, device lists and compliance checklists do not need separate signatures from the quality manager.

Where QMS-controlled procedures, quality manuals and device specification documents already carry author, reviewer and approver signatures, no further signatures are needed.

If a document is more than three years old and its validity at application cannot be confirmed, additional evidence is needed. This may include wording in the site's Annex 2 conformity declaration confirming that the documents remain current.

Contact BCG for further information.

https://emedi.mfds.go.kr/gmp/aply/view/MNU20284?searchType=ALL&pageNum=2&&pstSno=5&bbsSno=1339