Spike Pharmaceutical Factory Organize Simulation Filling Training
3Month27day,28On the same day, the preparation workshop and powder injection workshop of the peak pharmaceutical factory organized staff to carry out training on simulated filling knowledge.3Month31The eye drops line is prepared for simulated filling.
According to the requirements of the relevant documents,"Simulated filling”The word was changed“Aseptic process simulation test”. This training was conductedQAThe main speaker of the verification team introduced the aseptic process simulation test scheme from the aspects of verification purpose, description of verification process, risk assessment, culture results of culture medium after filling, etc., and analyzed in detail the situation of each link of the simulation filling, emphasizing that the staff of preparation, bottle management, stopper addition and filling should maintain standard behavior and should not move significantly in clean areas. At the same time, the employees also learned the "sterile drug site management practices".