To explore the common factors that influence the error of microbial limit testing of drugs and put forward preventive suggestions accordingly. Methods: a total of 100 batches of drug samples tested in a laboratory fro...To explore the common factors that influence the error of microbial limit testing of drugs and put forward preventive suggestions accordingly. Methods: a total of 100 batches of drug samples tested in a laboratory from January 2020 to June 2020 were selected as the analysis objects. The test related data were analyzed to summarize the common and typical factors affecting the error of microbial limit test. The error factors were analyzed and targeted intervention measures were sought. Results: among the included samples, there were 29 batches of errors, and the error rate was 29.0%. The main influencing factors for the errors of microbial limit test data included culture medium and colony count, drug preparation process, drug properties, testing equipment, etc., and more than 60% of the errors were affected by various factors. Conclusion: in the process of drug testing, there are many factors that may affect the accuracy of microbial limit testing. In the process of testing, it is necessary to strictly follow the concept of aseptic operation and have a standard system to guide the operation process, so as to reduce the risk of error as far as possible.展开更多
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To explore the common factors that influence the error of microbial limit testing of drugs and put forward preventive suggestions accordingly. Methods: a total of 100 batches of drug samples tested in a laboratory from January 2020 to June 2020 were selected as the analysis objects. The test related data were analyzed to summarize the common and typical factors affecting the error of microbial limit test. The error factors were analyzed and targeted intervention measures were sought. Results: among the included samples, there were 29 batches of errors, and the error rate was 29.0%. The main influencing factors for the errors of microbial limit test data included culture medium and colony count, drug preparation process, drug properties, testing equipment, etc., and more than 60% of the errors were affected by various factors. Conclusion: in the process of drug testing, there are many factors that may affect the accuracy of microbial limit testing. In the process of testing, it is necessary to strictly follow the concept of aseptic operation and have a standard system to guide the operation process, so as to reduce the risk of error as far as possible.
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.
