Weeks |
QC (quality control) of Biological product |
QA (quality assurance) of Biological GMP |
Out put |
|
1st |
Introduction of PT. Daewoong Infion |
|
2nd |
What is biological products |
|
3th |
Buffer preparation |
Review of GMP SOP |
SOP |
4th |
SDS-PAGE (theory/practice) |
AHU (air handling unit) |
Test results |
5th |
HPLC (theory/practice) |
WFI (water for injection) |
Test results |
6th |
IEF (theory/practice) |
Environmental Monitoring |
Test results |
7th |
LAL Test (theory/practice) |
Validation Master Plan |
Test results |
8th |
Presentation and evaluation of final report |
Report |