英国药监局OOS翻译 - 图文

MHRA-英国医药与保健食品管理局

Laboratory Analysis

Investigations of \-results\

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 batch 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） – Previous 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 criteria.

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 & S3 testing; 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, S2 & S3试验；含量均匀度规范要求增加20个样品；无菌试验）

However if the sample test criteria is usually the first level of testing and a sample has to be tested to the next level this should be investigated as it is not following the normal trend.

然而，如果样品试验标准通常在第一实验水平，样品的检测却在下一个水平，这种情况需要调查，因为它不是正常趋势。

? The OOS process is not applicable for In-process testing while trying to achieve a manufacturing process end-point i.e. adjustment of the

manufacturing process. (e.g. pH, viscosity), and for studies conducted at variable parameters to check the impact of drift (e.g. process validation at variable parameters).

OOS程序不适用于为了达到生产过程重点而开展的中间过程检测。即判定生产过程（如PH、粘度），及为了研究可变参数以检查漂移的影响（如可变参数的过程验证）

Out-of-Specification (OOS) Result –OOS结果

– Test result that does not comply with the pre-determined acceptance criteria (i.e. for example, filed applications, drug master files, approved marketing submissions, or official compendia or internal acceptance criteria).

– Test results that fall outside of established acceptance criteria which have been established in official compendia and/or by company documentation (i.e., Raw Material Specifications, In-Process/Final Product Testing, etc.).

-试验结果不符合已制定接受标准（即: 例如 申请材料、药品主文件、批准的销售合同、官方通则、内控标准） - 试验结果超出已建立的接受标准，这些标准在官方通则或者公司文件中规定了（即：原料标准、中间产品/成品检验标准等） ? Out of Trend (OOT) Result –

– Is generally a stability result that does not follow the expected trend, either in comparison with other stability batches or with respect to previous results collected during a stability study.

通常是一个稳定性考察结果不符合预期的趋势，包括其他批次稳定性数据趋势或者同以往稳定性研究结果数据趋势。

However the trends of starting materials and in-process samples may also yield out of trend data. The result is not necessarily OOS but does not look like a typical data point.Should be considered for environmental trend analysis such as for viable and non viable data (action limit or warning limit trends) 然而，原物料的趋势以及中控样品也会产生趋势数据。这些结果不需要OOS，但是不能看做为典型数据点，应当被看做环境趋势分析，例如可接受的或者不可接受的数据（行动线或者警戒线趋势）

? Atypical / Aberrant / Anomalous Result –

– Results that are still within specification but are unexpected, questionable, irregular, deviant or abnormal. Examples would be chromatograms that show unexpected peaks, unexpected results for stability test point, etc. 非典型/异常结果-

虽然在标准范围内但是非期望的、可疑的、不正常的数据。例如色谱图中的出现异常的峰、稳定性考察中的非期望结果。