无菌工艺模拟试验中存在的问题与对策

目的：了解企业在无菌工艺模拟试验中存在的问题，把握《无菌工艺模拟试验指南》技术要求，促进企业规范开展无菌工艺模拟试验，提高无菌药品的无菌保障水平。方法：统计分析2016-2018年山东省药品GMP认证中无菌工艺模拟试验开展情况，对缺陷项目进行分类归纳，并结合《无菌工艺模拟试验指南》的要求提出解决对策。结果：无菌工艺模拟试验中的问题集中在培养与观察、最差条件选择、干预设计、记录、模拟介质评价、人员培训与操作6个方面。结论：建议企业关注灌装产品的培养与观察、合理设计最差条件和干预、充分评价模拟介质、重视人员培训与操作，确保规范开展无菌工艺模拟试验。

Problems and Countermeasures in Simulating Testing of Aseptic Process

Objective: To understand the problems in simulating testing of aseptic process and make improvement to meet the technical requirements described in Guidance for Simulating Testing of Aseptic Process, promote drug manufacturing companies to perform the simulating testing of aseptic process in a right way, and improve the sterility assurance level of sterile drugs. Methods: The carrying out of the simulating testing of aseptic process in GMP certification work of manufacturers in Shandong Province from 2016 to 2018 were statistically analyzed. The frequent observed deficiencies were classified and summarized. Moreover, countermeasures were put forward according to the requirements of Guidance for Simulating Testing of Aseptic Process. Results: The problems in the simulating testing of aseptic process are as follows, incubation and media visual inspection, worst case design, intervention of design, recording, evaluation of simulation medium, personnel training and operation. Conclusion: It is recommended that the pharmaceutical companies should pay attention to the incubation and visual inspection of the filled products, rationally design the worst cases and interventions, fully evaluate the simulation medium, emphasize on personnel training and operation to ensure that simulating testing of aseptic process is carried out properly.