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.

伴随当今医疗水平的提升，社会更加提升了对药品安全的重视度与需求度。为了在药品生产中精准且客观反馈出药品安全生产的质量，医药企业对微生物鉴定技术的应用也相当的广泛。

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.

微生物鉴定技术的应用，加强了微生物的溯源分析，溯源分析是通过对污染微生物和相关环节监控微生物进行比对，以同源性的差异程度为依据，确认污染来源的过程。

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.

菌株水平的鉴定在污染调查过程中非常重要，尤其适用于产品中的微生物数量较高且符合标准要求时或出现异常高的微生物检出时。菌株水平的鉴定在无菌工艺中也很重要，在无菌试验结果阳性和培养基灌装等模拟工艺失败时，应对检出的微生物进行评估。

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.

同一地点的同种菌，其表型特征和基因型特征是基本一致的，不同地点的同种菌，表型特征可能基本一致，但保守及可变区域的基因特征会有一定的差异性。因此，污染调查等应以基因型特征鉴定为主，表型特征鉴定为辅。

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.

除了无菌产品需要进行微生物鉴定外，其他类型的产品也建议增加微生物鉴定的手段，并建立企业的菌种库。对受控环境收集到的微生物进行适当水平的鉴定，微生物菌群信息有助于预期常见菌群，并有助于评估清洁或消毒规程、方法、清洁剂或消毒剂及微生物监测方法的有效性，尤其当超过监测限度时，微生物鉴定信息有助于污染源的调查。关键区域分离到的菌落应先于非关键区域进行鉴定。

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:

微生物鉴定方法的运用前必须进行方法确认。微生物的鉴定方法的确认应包括准确度、专属性、重现性、灵敏度、阳性预测值（PPV）、阴性预测值（NPV）。微生物鉴定系统的确认试验按下述方法之一进行：

1. 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.
2. 采用现有方法和待确认方法对日常检验中分离的微生物约50株进行平行鉴定试验，鉴定结果的差异可使用仲裁方法判定。
3. Conduct a total of 50 identification experiments using 12-15 known reserve strains that can represent the commonly isolated microorganisms.
4. 使用12-15种已知的能代表常规分离到的微生物的储备菌种，共进行50次鉴定试验。
5. 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.
6. 待确认方法对20-50株微生物（包括15-20个不同的种）进行鉴定，结果应与参照实验室的鉴定结果一致。

Evaluate the identification results of the microbial identification system used, while also considering its consistency level.

对所用的微生物鉴定系统的鉴定结果进行评估，同时还应考虑其一致性水平。