如果按照类别，属于OOS调查. （Out of specification）

不过根据之前公司经验，发生OOS后，需要启动实验室调查. 

如果在实验室调查过程中，发现对照品异常， 则属于实验室调查的范畴， 而OOS属于Deviation范畴. 供参考.

FDA 对OOS的定义：The term OOS results includes all test results that fall outside the specifications or acceptance criteria established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer. The term also applies to all in-process laboratory tests that are outside of established specifications.

MRHA对OOS的定义： Investigations of "Out of Specification (OOS) / Out of Trend (OOT)/ Atypical results" have to be done  in cases of:

• Batch release testing and testing of starting materials.
• In-Process Control testing: if data is used for batch calculations/decisions and if in a dossier and on Certificates of Analysis.
• Stability studies on marketed batches of finished products and or active pharmaceutical ingredients, on-going / follow up stability (no stress tests)
• Previous released batch used as reference sample in an OOS investigation showing OOS or suspect results.
• Batches for clinical trials.

这两个定义都说明实验室的检验、已建立标准，超出标准范围，就应该进行OOS调查。标准品是用于产品放行，标准品标定过程超出自己设定的标准，也应该进行OOS调查。

各法规指南都没有非常明确的说OOS是特指超出产品的质量标准。 这个OOS都是根据各个企业自己的定义，如果看指南的定义超出标准即为OOS，有物料的，中间产品的，稳定性研究的等等，只要有标准都是OOS，只不过调查的程度，影响的范围不一样，这个各个企业可以根据风险自己定义。

标定既然有标准，严格意义上来说，也是一类OOS！重点，也是在于确认，标定结果是否准确！