[GMP Update] Handling Omitted Audit Information (June 2023).

If an on-site audit reveals intentionally or accidentally omitted documents or incorrect application information, the planned audit duration may need to be revised. MFDS advised establishing a response for such cases.
Example: The site's actual employee count is more than twice that declared, requiring additional auditor-days or auditors.

Review bodies should thoroughly examine the submitted documents and confirm details with the company before the visit.

If extra auditor-days or auditors are still needed after on-site checks, agree with the company on extending or rescheduling the audit.

Contact BCG for further information.

https://emedi.mfds.go.kr/gmp/aply/view/MNU20284?searchType=ALL&pageNum=3&&pstSno=4&bbsSno=1339