Objective: to discuss the related factors affecting the quality control of pharmaceutical microorganism testing laboratories and their countermeasures. Methods: the computer was used to collect the occurrence of detec...Objective: to discuss the related factors affecting the quality control of pharmaceutical microorganism testing laboratories and their countermeasures. Methods: the computer was used to collect the occurrence of detection bias samples in the pharmaceutical microbiology laboratory of our hospital. The retrieval period was set as June 2019 to August 2020. The causes of the bias samples were sorted out and analyzed, and the corresponding measures were formulated. Results: after investigation and statistics, 109 samples of testing deviation occurred in our hospital's pharmaceutical microorganism testing laboratory, among which the non-compliance of personnel's operation was the main reason, accounting for 34.86%. The second was the testing deviation caused by equipment problems, testing methods and standard problems, accounting for 26.61% and 14.68% respectively. Conclusion: the factors affecting the quality control management of pharmaceutical microorganism testing laboratories involve various aspects, and the laboratories should pay attention to them and formulate specific measures to prevent specific problems in order to reduce the occurrence of testing deviation events and improve the quality control management of laboratories.展开更多
文摘Objective: to discuss the related factors affecting the quality control of pharmaceutical microorganism testing laboratories and their countermeasures. Methods: the computer was used to collect the occurrence of detection bias samples in the pharmaceutical microbiology laboratory of our hospital. The retrieval period was set as June 2019 to August 2020. The causes of the bias samples were sorted out and analyzed, and the corresponding measures were formulated. Results: after investigation and statistics, 109 samples of testing deviation occurred in our hospital's pharmaceutical microorganism testing laboratory, among which the non-compliance of personnel's operation was the main reason, accounting for 34.86%. The second was the testing deviation caused by equipment problems, testing methods and standard problems, accounting for 26.61% and 14.68% respectively. Conclusion: the factors affecting the quality control management of pharmaceutical microorganism testing laboratories involve various aspects, and the laboratories should pay attention to them and formulate specific measures to prevent specific problems in order to reduce the occurrence of testing deviation events and improve the quality control management of laboratories.
