There could be equipment failures or changes in the raw materials used. The process could be financially OOC (i.e., losing money), or out-of-regulatory-control with cGMP violations.
Oct 1, 2011
People also ask
What is OOS and OOT?
1. OOS (out of specification) is the comparison of one result versus predetermined specification criteria while OOT (Out of Trend) is the comparison of many historical data values versus time.
What does OOS mean in manufacturing?
Out-of-Specification (OOS) Results A result that falls outside established acceptance criteria which have been established in official compendia and/or by company documentation.
What is out of trend in pharma?
Out of trend (OOT), results are those results that are within the specification but indicate that the particular analysis or process could be out of control.
How do you do an OOS investigation?

Checklist for OOS Investigation

Analyst errors. Analysts must investigate for laboratory errors which can occur when analysts make analytical mistakes. ...
Instrument/ Equipment Errors. ...
Laboratory System Errors. ...
Operator Error. ...
Equipment Error. ...
Production Control System Error.
Jan 7, 2020 · To alleviate confusion about being out-of-control (OOC), this column proposes concepts and definitions for the industry.
OOC, Out of Calibration ; OOC, Out of Cycle ; OOC, Out of Concentration (Dark Age of Camelot online game) ; OOC, Oil on Cuttings.
Feb 5, 2020 · OOC stands for Out of calibration. AA stands for the last two digits of the current year ( for the year 2020, ...
Result: Calibrated by/date
In-line inspection is designated to detect out-of-control (OOC) performance in order to increase quality output, and thus profit.
Define OOC. means the Oversight and Operations Committee.
Missing: manufacturing | Must include:manufacturing
The main objective of the pharmaceutical industry when manufacturing and ... of a qualification/calibration is OOC when the result of at least one of the ...
Download scientific diagram | OOC performance of the proposed and existing charts under different environments. from publication: Enhanced nonparametric ...
Download Table | OOC pattern based on individual control chart points from publication: Progressive measurement and monitoring for multi-resolution data in ...
... In-depth analysis on the market status of the Organ-On-Chip (OOC) Top manufacturers with best facts and figures, meaning, Definition, SWOT analysis, ...