GLPGCP GLPGCP
16 915 335
300 EU GMP 2
B B
GMP
GMP
H.5 GCP GCP H.2 H.9 H.15 H.17 GCP GCP /
GCP GCP GCP GCP
GCP GCPGCP 8
GCP GCPGCP 9 GCP GCPGCP 10
GCP GCP GCP GCP
GLP LP GLP 3
4
6 FDA GVP
Essential Principles) Summary Technical Documents)
db/dt SAR S/N
I
(1) (2) (3) (1) (2) (3)
(Summary documents of pre-clinical design verification and validation) (1) (1) (2) (3) (4) (5) (6) (Clinical evidence) (1) (2) (3)
1) GMP 2) 1) 2) GMP
I
GMPISO13485
JIS JIS
GMPISO13485
16 915 335