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OOS & OOT
Reliable test results provide necessary proof of quality of
products. Reliable test results can be achieved if and only if,
- The method used has been scientifically validated and in
compliance of GMP regulations & method validation guidelines of
the ICH & the FDA,
- SOPs, which cover all aspects of sampling and determination, are
well written, accurate, consistent, executable, and in compliance of
- Employees are trained and their competencies are documented,
- SOPs have been followed accurately for sampling and determinations
- The measurement system is in state of statistical control,
- Electronic records & electronic signatures comply to 21 CFR
- Non-electronic records and handwritten signatures comply with GMP.
Out of specification (OOS) results includes all suspect
results that fall outside the specifications or acceptance criteria
established in new drug applications, official compendia, or by the
Out of trend (OOT) results includes all suspect results
that fall outside the trend specifications or acceptance criteria for
the trends established in new drug applications, official compendia, or
by the manufacturer.
OOS results can be classified into one (1) of three (3)
non-process related (e.g., manufacturing equipment) or operator error,
process related or manufacturing process error.
Each technique must be considered specifically relative to OOS
& OOT investigations.
Laboratory errors occur when analysts
make mistakes in following the SOPs,
uses incorrect standards, and/or
uses incorrect materials, and/or
uses incorrect supplies, and/or
simply records the results erroneously, and/or
miscalculates the data, and/or
simply does not have sufficient level of competency in carrying out the
We shall be concerned with recognizing laboratory errors in QC
testing, the relevant competency requirement of the analysts and supervisors,
preventative strategies to minimize OOS & OOT, and the process of
effective investigations to resolve OOS & OOT.