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1、MHRA-英国医药与保健食品管理局Laboratory AnalysisInvestigations of “Out of Specification (OOS) / Out of Trend (OOT)/ Atypical - results“ have to be done in cases of: 在如下情况下应开展OOS /OOT /异常结果结果调查 Batch release testing and testing of starting materials. 批放行检验及原物料检验 In-Process Control testing: if data is used for ba
2、tch alculations /decisions and if in a dossier and on Certificates of Analysis. 过程控制检验：如果数据用作在记录或者检验报告作为批计算/决定 Stability studies on marketed batches of finished products and or active pharmaceutical ingredients, on-going / follow up stability (no stress tests) 成品和/或原料药市售批次的稳定性研究，用作持续跟踪稳定性（非破坏性试验） Pr
3、evious released batch used as reference sample in an OOS investigation showing OOS or suspect results. 产品放行批之前在OOS调查中的参考品显示OOS或者非预期结果。 Batches for clinical trials.临床试验批 All solutions and reagents must be retained until all data has been second person verified as being within the defined acceptance c
4、riteria. 所有溶液和实际必须保留，直到数据被第二个人证实在规定的可接受标准内。 Pharmacopoeia have specific criteria for additional analyses of specific tests (i.e. dissolution level specification for S1, S2 Uniformity of dosage units specification for testing of 20 additional units; Sterility Testing). 药典明确规定需要增加额外的特定实验分析（例如：分散水平规范S1
5、, S2 analysis to be repeated” on all associated analytical documentation.分析人及主管记录这一事件，并注明“断电，需复检”在所有关联的分析记录中。 Equipment failure 仪仪器器错误错误analyst and supervisor document the event, annotate “equipment failure; analysis to be repeated” cross reference the maintenance record.分析人及主管记录这一事件，注明“仪器错误，需复检”并索引
6、至仪器维护记录。 Testing errors 试验错误试验错误 for example, spilling of the sample solution, incomplete transfer of a sample; the analyst must document immediately. for microbiology it could be growth on a plate not in the test sample area, negative or positive controls failing.例如，样品溶液倾洒，样品转移不完全；分析人应立即记录。对于微生物分析，
7、可能出现微生物生长在非样品区域的平皿中，阴性或阳性对照失败。 Incorrect Instrument Parameters 错误错误的的仪仪器参数器参数设设置置for example setting the detector at the wrong wavelength, analyst and supervisor document the event, annotate “incorrect instrument parameter”; analysis to be repeated” on all associated analytical documentation . 例如，检测
8、器波长设置错误，分析人及主管记录这一事件，注明“错误的仪器 参数，需复检”在所有关联的分析记录中。 If no error was noted, and none of the above conditions were met Phase Ib investigation must take place.如果没有如果没有错误错误被被记录记录，上述条件都没有，上述条件都没有发发生，生，应应开展步开展步骤骤1b调查调查Phase Ib Investigation Definitions定义定义Specification 标准标准 A specification is defined as a l
9、ist of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a drug substance, drug product or materials at other stages of its manufacture should conf
10、orm to be considered acceptable for its intended use. “Conformance to specification” means that the drug substance and drug product, when tested according to the listed analytical procedures, will meet the acceptance criteria. Specifications are critical quality standards that are proposed and justi
11、fied by the manufacturer and approved by regulatory authorities as conditions of approval. 标准被定义为一组测试，参照分析程序，及适当的接受条件，这些标准应为数标准被定义为一组测试，参照分析程序，及适当的接受条件，这些标准应为数 字限度、范围或这一组测试描述的其他条件。建立的这套在生产过程各阶段的字限度、范围或这一组测试描述的其他条件。建立的这套在生产过程各阶段的 药物、药品或材料的标准，如果达到，应当被认为就符合其预定用途。药物、药品或材料的标准，如果达到，应当被认为就符合其预定用途。“符合符合 标准标
12、准”意味着药物以及药品，当按照这套分析程序检验，达到了可接受条件。意味着药物以及药品，当按照这套分析程序检验，达到了可接受条件。 标准是判定性的质量标准，它是有生产厂家提出并证实，由法规机构作为批准标准是判定性的质量标准，它是有生产厂家提出并证实，由法规机构作为批准 条件颁发的。条件颁发的。 Regulatory Approved Specification 法定标准法定标准 Specifications for release testing. If no release specifications have been established then the internal speci
13、fication becomes the release specification.放行试验标准。如果没有放行标准被建立，那么中间控制标准即为放行标准。 Acceptance Criteria 可接受标准可接受标准 Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures which the drug substance or drug product or materials at other stages of their manu
14、facture should meet.生产各过程的药物、药品或物料应当符合限度、范围或者分析过程结果的其他合适的可接受方式。 Internal Specification 中间标准中间标准 Are also action limits within regulatory specifications. 法定限度内的行动线。 Assignable Cause 明确原因明确原因 An identified reason for obtaining an OOS or berrant/anomalous result.出现OOS或者异常结果的被确定的原因 No Assignable Cause 非
15、明确原因非明确原因 When no reason could be identified.无法确定的原因 Invalidated test 无效实验无效实验 A test is considered invalid when the investigation has determined the assignable cause.经调查确定可指明原因，试验被认为无效。 Reportable result 可报告结果可报告结果 Is the final analytical result. This result is appropriately defined in the written
16、approved test method and derived from one full execution of that method, starting from the original sample. 为最终分析结果。使用书面的批准方法适当的明确并且从这一方法完整执行后 得到的结果，此结果从原始样品的检测结果。 Warning Level or Trend excursions 警戒水平或者趋势偏离If two or more consecutive samples exceed warning (alert), or if an increasing level of counts, or same organisms identified, over a short period was identified consideration should be given to treat the results as a
