[GMP Update] Applying the Continuous-Process Approach (September 2023).

Under the GMP application guide's manufacturing-site instructions, only sites performing key manufacturing processes should be named on the certificate.

Applicants should review the relationships between the sites' QMSs and list only those sites performing key processes, rather than merely subsidiary steps.

The continuous-process approach is not limited to multiple sites owned by the applicant; it also covers third-party sites performing key processes.

MFDS advised applying the definitions of manufacturer and key manufacturing process in Annex 1, items 58 and 68, of the GMP standards, rather than listing every site performing any part of the manufacturing process.

Contact BCG for further information.

https://emedi.mfds.go.kr/gmp/aply/view/MNU20284?searchType=ALL&pageNum=2&&pstSno=7&bbsSno=1339