What’s the meaning of “oos” in pharmaceutical companies?

What are oos and oot in drug analysis

OOT is called OutOfTrendsresults. It is a result or series of results that are within specification limits but exceed expectations (e.g., new degradation impurities added, abnormal stability data).

OOS is called OutOfSpecificationresults. It is exceeding the specification limits and generally refers to results exceeding the limits of the standard established.

OOT alert limit is established to monitor the situation that may produce potential OOS, early detection of abnormal trends and investigate rather than wait until the OOS results come out to investigate the situation, so that early detection of possible problems, better control of product quality.

Both are indicators used by the quality system to measure deviation, OOS is to look for deviation after exceeding the standard, while OOT is to look for deviation when it does not exceed the standard but reaches the warning value.

For example, the material check, single impurity more than 0.1% is unqualified, but in the research and development process if there is an impurity more than 0.05% you have to characterize the impurity. This is the OOT.

And the OOS is when you find an impurity that exceeds the 0.1% limit during the inspection process, and the deviation at that point is the oos.

This example is just one aspect of the OOT, and there are more detailed classifications of specific OOTs that cover design, production, and inspection steps, which are covered in detail in the FDA’s OOS instructions.

All hand-typed except for definitions.

The Chinese and English meanings of OOT and OOS in pharmacy pharmaceutical

OOS:outofspecification exceeds the standard

OOT:outoftrend exceeds the trend

What is the meaning of oosoot in quality management

Oos in quality management refers to the deviation of the test results, and oot refers to the deviation of the results of the experimental data beyond the expected standard.

The main definitions of oos and oot are:

oos full name outofspecification: refers to the laboratory results do not meet the statutory quality standards or the results of the enterprise’s internal control standards, including stability studies in the product does not comply with the quality standards within the validity period of the results;

oot full name outoftrend: refers to the test The results, although in line with the standard provisions, but significantly deviated from the historical test results.