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H Out-of-specification results
Here you will find answers to the following
questions:
What is an OOS result?
For which areas do the guidelines apply?
What is the procedure and what must be
taken into consideration?
What demands are to be made on the
documentation?
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Analytical error: Deviation of an analytical result
from the true value due to mistakes made when
carrying out the testing e.g. as a consequence
of technical problems.
Product error: Deviation of an analytical result
from the true value due to insufficient product
quality as a consequence of failure in
manufacturing.
Sample error: Deviation of an analytical result
from the true value due to a failure in sample
preparation, e.g. sampling, sample mix-up,
incorrect labelling, change in quality of samples.
Unknown error: Deviation of an analytical result
from the true value due to an error that cannot
be assigned to the first three categories.
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active pharmaceutical ingredients (IPC) and
final inspection of active pharmaceutical
ingredients, for excipients, for other components
and for finished products.
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B. Responsibility of the supervisor
In the event of OSS results, the supervisor
must proceed with the investigation
objectively, promptly and impartially.
Possible laboratory errors must be clarified
immediately providing that the test solutions
are still available (note: and stable).
The following steps must be assessed:
Discuss the method with the analyst
making sure that everything has been
properly understood and correctly carried
out.
Investigate raw data (chromatogram,
spectra).
System suitability test.
Check standards, solvents, reagents.
Check efficiency of method - also
against validation.
Document everything completely.
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General investigational principles
The investigation should be documented on
a step-by-step basis in the written records
as follows:
Reason for investigation
Summary of critical manufacturing steps
Document check with statement of real
or possible causes
Check for any previous cases of a
similar nature
Corrective action
A. Laboratory phase of an investigation
The following options are available for this
investigation:
Retesting of a partial quantity of the
original sample
The same sample that was originally
another analyst.
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taken with respect to inconclusive results.
Statistical approaches (outlier tests) are
generally not permissible for chemical analyses.
Reporting
For registration batches, the authorities must be
informed within 3 working days about an OOS
result
Flow diagram
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