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发表于 2020-11-12 17:35:47
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第二百二十六条 试剂、试液、培养基和检定菌的管理应当至少符合以下要求：
Article 226: The management of laboratory reagents, solutions, culture media and test microorganisms should meet at least the following requirements:
（一）试剂和培养基应当从可靠的供应商处采购，必要时应当对供应商进行评估；
 Laboratory reagents and culture media should be purchased from reliable suppliers, and when necessary, the supplier should be assessed.
（二）应当有接收试剂、试液、培养基的记录，必要时，应当在试剂、试液、培养基的容器上标注接收日期；
There should be records for the receipt of laboratory reagents, solutions and culture media, the date of receipt should be indicated on the container where necessary. 
（三）应当按照相关规定或使用说明配制、贮存和使用试剂、试液和培养基。特殊情况下，在接收或使用前，还应当对试剂进行鉴别或其他检验；
The preparation, storage and use of the laboratory reagents, solutions and culture media should follow the relevant requirements or instructions. In special cases, the laboratory reagents should be identified or tested upon reception or before use.
（四）试液和已配制的培养基应当标注配制批号、配制日期和配制人员姓名，并有配制（包括灭菌）记录。不稳定的试剂、试液和培养基应当标注有效期及特殊贮存条件。标准液、滴定液还应当标注最后一次标化的日期和校正因子，并有标化记录；
The batch number, preparation date, and name of the operator should be indicated on the labels of solutions and prepared culture media, and a preparation record (including sterilization) should be available. The shelf life and special storage conditions of unstable laboratory reagents, solutions and culture media should be indicated on the label. For reference solutions and titration solutions, the latest standardization date and calibration factor should be labeled, and the standardization records should be available. 
（五）配制的培养基应当进行适用性检查，并有相关记录。应当有培养基使用记录；
Test on suitability of prepared culture media should be performed and documented. The records for use of culture media should be available.
（六）应当有检验所需的各种检定菌，并建立检定菌保存、传代、使用、销毁的操作规程和相应记录；
Microorganisms required for relevant tests should be available. And operation procedures for storage, subculture, use, and disposal of test microorganisms should be established and recorded accordingly.
（七）检定菌应当有适当的标识，内容至少包括菌种名称、编号、代次、传代日期、传代操作人；
The test microorganism should be properly labeled with at least the following information: name of microorganism, code, generation, generation date/subculture date and operator.
（八）检定菌应当按照规定的条件贮存，贮存的方式和时间不应当对检定菌的生长特性有不利影响。
The test microorganism should be stored according to the specified storage conditions. The manner and period of storage should not have adverse effects to the growth characteristics of the test microorganism.
第二百二十七条 标准品或对照品的管理应当至少符合以下要求：
Article 227: The management of the standard substances or reference substances should meet at least the following requirements:
（一）标准品或对照品应当按照规定贮存和使用；
The standard substances or reference substances should be used and stored under specified storage conditions.
（二）标准品或对照品应当有适当的标识，内容至少包括名称、批号、制备日期（如有）、有效期（如有）、首次开启日期、含量或效价、贮存条件；
The standard substances or reference substances should be properly labeled with at least the following information: name, batch number, data of preparation (if available), shelf life (if available), open date, purity or titration, and storage condition.
（三）企业如需自制工作标准品或对照品，应当建立工作标准品或对照品的质量标准以及制备、鉴别、检验、批准和贮存的操作规程，每批工作标准品或对照品应当用法定标准品或对照品进行标化，并确定有效期，还应当通过定期标化证明工作标准品或对照品的效价或含量在有效期内保持稳定。标化的过程和结果应当有相应的记录。
Where in-house working standard substances or reference substances are to be self-prepared, the manufacturer should establish specifications of the working standards and operation procedures for the preparation, identification, testing, approval and storage. Each lot of in-house working standard substance or reference substance should be standardized against an official standard substance or reference substance, and shelf life established. In addition, the working standard substances or reference substances s should be standardized regularly to demonstrate that their potency or assay is stable within shelf life. The process and result of the standardization should be recorded. |
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