化學(xué)藥品注射劑是臨床上應(yīng)用較廣的一類無(wú)菌藥品，鑒于其較高的安全性風(fēng)險(xiǎn)，確保注射劑的無(wú)菌性尤為關(guān)鍵。結(jié)合中國(guó)、美國(guó)和歐盟對(duì)注射劑的無(wú)菌保障監(jiān)管及藥品生產(chǎn)質(zhì)量管理規(guī)范（GMP）指南的現(xiàn)行要求，進(jìn)一步探討化學(xué)藥品注射劑的滅菌或無(wú)菌工藝控制。目前，我國(guó)化學(xué)藥品注射劑的滅菌或無(wú)菌工藝選擇要求與歐美國(guó)家基本一致，美國(guó)和歐盟對(duì)于濕熱滅菌注射藥品已實(shí)施參數(shù)放行。通過(guò)闡述注射劑滅菌或無(wú)菌工藝的評(píng)估及研究，為制藥企業(yè)化學(xué)藥品注射劑無(wú)菌保障控制策略及無(wú)菌風(fēng)險(xiǎn)管控的不斷完善提供參考，以更好地提高注射劑的無(wú)菌保障。

Parenteral drug was a kind of sterile products and widely used in clinical. Based on highly safety risk, it was particularly important to ensure the sterility assurance. To discuss the sterilizing or aseptic process control requirements of parenteral drug, compared China, the United States and the European Union. The requirements with those countries were similar, the United States and the European Union implemented parametric release of parenteral drug terminally sterilized by moist heat. With the evaluation and research on sterilizing or aseptic process, this paper provided reference for pharmaceutical to improve the strategy for parenteral drug, and strengthen the sterility of products.