[GMP Update] Software Manufacturing Sites Sharing an Address.

MFDS advised that two GMP certificates for the same address should be managed as a single certificate where different product groups have different periodic audit schedules, to simplify administration.

However, consolidating under the certificate with the longer remaining validity could extend the audit cycle for product groups whose certificates expire sooner, creating a potential quality oversight gap.

Additional product groups are entered on an existing certificate. At the company's request, they may be added through reissue of the certificate with the shorter remaining validity.

Contact BCG for further information.

https://emedi.mfds.go.kr/gmp/aply/view/MNU20284?&pstSno=5&bbsSno=1341