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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
183 184
facilities and equipment preparation,184
184
filling/closing/stoppering/sealing,191
191
finishing and inspection,192,193
192 193
in-process testing,190
190
manufacturing procedures,180
180
quality control testing,192,193
192 193
terminal serilization,192
192
Sterile product manufacturing process clean rooms,7
7
products production equipment,184
184
Sterile manufacturing facilities,211,220
211 220
clean room classified areas aseptic area,217,218
217 218
functional areas,212,213
212 213
materials of construction,215,217
215 217
modular construction,218,219
218 219