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无菌药品按生产工艺可分为2类:最终灭菌产品采用最终灭菌工艺;非最终灭菌产品采用部分或全部工序无菌生产工艺,无菌药品的生产必须严格按照规程进行,产品的无菌或其他质量特性不能只依赖于任何形式的最终处理或成品检验。因此,无菌粉针剂生产中硬件设施的性能是保证产品无菌的前提。文章以非最终灭菌的无菌粉针注射剂生产为例,阐述如何结合新版GMP的实施在关键工艺操作上采用新的工程控制措施,以确保生产出合格的无菌产品。
Sterile drugs according to the production process can be divided into two categories: the final sterilization of products using the final sterilization process; non-final sterile products using part or all of the aseptic process, aseptic drugs must be strictly in accordance with the rules of production, product Sterility or other quality characteristics can not depend on any form of final treatment or finished product inspection. Therefore, the performance of the hardware facilities in the production of sterile powder injection is a prerequisite for ensuring the sterility of the product. The article takes non-final sterilized sterile powder injection as an example to illustrate how to incorporate new engineering controls into key process operations in conjunction with the implementation of the new GMP to ensure the production of qualified sterile products.