Quality control analysis of validation of non sterile drug microbiological examination capability
Through the ability to verify the microbial inspection of non-sterile drugs,strengthen the quality control of enter-prise microbiology laboratory and improve the technical ability of microbial inspection and detection.Microbial limit test for non-sterile products was conducted according to the Chinese Pharmacopoeia 2020 Edition of General Rule 1105:Microbe counting method in the plate method(Pour method),Chinese Pharmacopoeia 2020 edition of General Rule 1106 for Non-sterile products Microbial Limit Test:Control bacteria test method and non-sterile drug microbial test ability verification operating instructions.The results showed that the total number of aerobic bacteria in sample 236 is 1.7×10 3 CFU/mL,the total number of mold and yeast in sample 316 is 9.5×10 2 CFU/mL,sample 321 Staphylococcus aureus and Pseudomonas aeruginosa were negative qualitatively;The results of the proficiency test sample are satisfactory,and the quality process is controllable.The testing laboratory has the technical capability of microbiological examination of non-sterile drugs to ensure the accuracy and reliability of test results.
Verification of abilityNon sterile drugTotal number of aerobic bacteriaTotal number of molds and yeastsChar-acterization of Staphylococcus aureus and Pseudomonas aeruginosa
万方数据
维普
