[Validation method for bacteria and fungi count in microbial limit test of drugs].

OBJECTIVE: To establish the validation method and criteria for counting bacteria and fungi in microbial limit test which is described in the Pharmacopeia of China (ChP) 2005. METHOD: According to the method set up for validation, the tested microorganisms with known counts were added to samples followed by the determination of the recovery. RESULT: With different preparing method for testing samples, the recoveries for the tested microorganisms in testing samples were found to be over 70%. CONCLUSION: Validation method for counting contaminated bacteria and fungi in drugs is recommended to follow the method established in this paper. The recovery for tested microorganisms should be not less than 70%.