With the improvement of today's medical level, society has increasingly attached importance and demand to drug safety. In order to provide accurate and objective feedback on the quality of drug safety production in drug production, pharmaceutical companies have also widely applied microbial identification technology.

With the improvement of today's medical level, the society has increased the importance and demand for drug safety. In order to accurately and objectively feedback the quality of drug safety production in drug production, the application of microbial identification technology in pharmaceutical enterprises is also quite extensive.

The application of microbial identification technology has strengthened the traceability analysis of microorganisms. Traceability analysis is the process of confirming the source of pollution by comparing contaminated microorganisms and related monitoring microorganisms based on the degree of homology differences.

The application of microbial identification technology strengthens the traceability analysis of microorganisms. Traceability analysis is a process of confirming the source of pollution by comparing the contaminated microorganisms and the monitoring microorganisms in related links, based on the degree of homology difference.

The identification of strain level is very important in the pollution investigation process, especially when the microbial quantity in the product is high and meets the standard requirements or when abnormally high microbial detection occurs. The identification of bacterial strains is also important in aseptic processes. In the event of positive results in aseptic tests or failure in simulated processes such as medium filling, the detected microorganisms should be evaluated.

The identification of the strain level is very important in the process of pollution investigation, especially when the number of microorganisms in the product is high and meets the requirements of the standard or when there is an abnormally high detection of microorganisms. Strain-level identification is also important in aseptic processes, and the microorganisms detected should be evaluated when simulated processes such as positive sterility test results and medium filling fail.

The phenotypic and genotypic characteristics of the same type of bacteria in the same location are basically the same. The phenotypic characteristics of the same type of bacteria in different locations may be basically the same, but there may be certain differences in the genetic characteristics of conservative and variable regions. Therefore, pollution investigations should mainly focus on genotype identification, with phenotype identification as a supplement.

The phenotypic characteristics and genotypic characteristics of the same bacteria in the same location are basically the same, and the phenotypic characteristics of the same bacteria in different locations may be basically the same, but the genetic characteristics of the conserved and variable regions will have certain differences. Therefore, the investigation of pollution should be based on the identification of genotypic characteristics, supplemented by the identification of phenotypic characteristics.

In addition to sterile products that require microbial identification, it is also recommended to increase the means of microbial identification for other types of products and establish a bacterial strain library for the enterprise. The appropriate level of identification of microorganisms collected in controlled environments can help predict common microbial communities and evaluate the effectiveness of cleaning or disinfection procedures, methods, cleaning or disinfectants, and microbial monitoring methods. Especially when monitoring limits are exceeded, microbial identification information can aid in investigating the source of pollution. Colonies isolated from critical areas should be identified before non critical areas.

In addition to the need for microbial identification of sterile products, other types of products are also recommended to increase the means of microbial identification, and the establishment of the enterprise's strain library. The appropriate level of identification of microorganisms collected from controlled environments, microflora information helps to anticipate common flora, and helps to evaluate the effectiveness of cleaning or disinfection procedures, methods, cleaners or disinfectants, and microbiological monitoring methods, especially when monitoring limits are exceeded, microbiological identification information helps to investigate the source of pollution. Colonies isolated from critical areas should be identified prior to non-critical areas.

Method microbial identification must be carried out before the application of microbial identification methods. The confirmation of microbial identification methods should include accuracy, specificity, reproducibility, sensitivity, positive predictive value (PPV), and negative predictive value (NPV). The confirmation test of the microbial identification system shall be carried out using one of the following methods:

The method must be confirmed before the application of the microbial identification method. Confirmation of microbial identification methods should include accuracy, specificity, reproducibility, sensitivity, positive predictive value (PPV), and negative predictive value (NPV). The confirmation test of microbiological identification system shall be carried out according to one of the following methods:

Parallel identification experiments were conducted on approximately 50 strains of microorganisms isolated in daily testing using existing and unconfirmed methods. Differences in identification results can be determined using arbitration methods.
The existing method and the method to be confirmed were used to carry out parallel identification test on about 50 strains of microorganisms isolated in daily inspection, and the difference of identification results can be determined by arbitration method.
Conduct a total of 50 identification experiments using 12-15 known reserve strains that can represent the commonly isolated microorganisms.
A total of 50 identification tests were performed using 12-15 known stock strains representative of regular isolated microorganisms.
The method to be confirmed is to identify 20-50 microbial strains (including 15-20 different species), and the results should be consistent with the identification results of the reference laboratory.
The identification of 20-50 strains of microorganisms (including 15-20 different species) by the method to be confirmed should be consistent with the identification results of the reference laboratory.
Evaluate the identification results of the microbial identification system used, while also considering its consistency level.

The identification results of the microbiological identification system used should be evaluated, taking into account the level of consistency.