[GMP Update] Combining Batch Periodic Applications with Other Audits (September 2023).

MFDS noted that review bodies differed on combining a batch periodic audit application with change or additional audits, which could confuse applicants.

It advised against combining them, in keeping with the original purpose of batch periodic applications.

Periodic audits use different criteria from change and additional audits. Combining them without extra auditor-days can limit the assessment.

The notice stated that, from 1 October 2023, batch periodic applications could not be combined with change or additional audits.

Contact BCG for further information.

https://emedi.mfds.go.kr/gmp/aply/view/MNU20284?searchType=ALL&pageNum=2&&pstSno=6&bbsSno=1339