[GMP Update] Limiting Repeated On-Site Audit Postponements (December 2023).

MFDS stated that, at the time of the notice, requested on-site audit postponements were processed by rescheduling without a limit on the number of postponements.

Repeated rescheduling of accepted applications can delay on-site audits for other companies.

Article 7(1) and (3) of the medical device GMP standards requires applicants to finalise the requested on-site audit date at least 20 days before the audit starts. For periodic audits, the requested date must be set at least 20 days before certificate expiry.

The October 2023 operating guidance requires prior notice that postponing a periodic audit beyond certificate expiry may result in suspension of sales after expiry.

Companies should be advised to avoid repeated postponements. Where unavoidable circumstances such as inadequate site readiness arise, the review body may need to advise resubmission.

For a postponed periodic audit, MFDS recommends documenting the reason clearly before proceeding.

Contact BCG for further information.

https://emedi.mfds.go.kr/gmp/aply/view/MNU20284?searchType=ALL&pageNum=2&&pstSno=9&bbsSno=1339