无菌药品:制剂,包装,制造和质量 1065条(本栏目收费,不能显示细节,电话13136136841)
water system validation,228 228
Sterile product manufacturing batch record and other documentation,183,184 184
facilities and equipment preparation,184 184
filling/closing/stoppering/sealing,191 191
finishing and inspection,192,193 193
in-process testing,190 190
manufacturing procedures,180 180
quality control testing,192,193 193
terminal serilization,192 192
Sterile product manufacturing process clean rooms,7 7
products production equipment,184 184
Sterile manufacturing facilities,211,220 220
clean room classified areas aseptic area,217,218 218
functional areas,212,213 213
materials of construction,215,217 217
modular construction,218,219 219