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OOS

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For more information about OOS, enter a question into the box above, or select from one of the questions below. You can select a different product from the list in the left hand panel.


Q:
How frequently is it reasonable to experience a lab error?
A: Laboratory error should be relatively rare. Frequent laboratory errors could mean one or more of the following: (1) inadequate training of the analysts, (2) poorly maintained equipment, (3) improperly calibrated equipment, (4) careless work.


Q:
What kind of transient equipment malfunction can occur in LAL-endotoxin kinetic testing and how can it be resolved?

Q:
Why do I need to conduct an investigation if an OOS test result is obtained?

Q:
What is the purpose of an OOS investigation?

Q:
Who should investigate OOS?

Q:
Which parts of the CGMP regulations apply to laboratory operations?

Q:
Which section of the CGMP regulations specifies that products failing to meet established standards and other relevant quality control criteria will be rejected?

Q:
How do I handle an OOT result?

Q:
Can I ignore an OOS investigation if the rejection of a batch is based on an OOS result?

Q:
Why is it necessary to carry out an OOS investigation if the rejection of a batch is based on an OOS result?

Q:
Which sections of the CGMP regulations require that written records of the investigation are made, including conclusions of the investigation and follow-up?

Q:
How do I carry out a meaningful OOS investigation?

Q:
What should the analyst do, whenever possible, before discarding the test solution?

Q:
When do I need to conduct a complete failure investigation?

Q:
Who is responsible for the first course of action?

Q:
Who has the primary responsibility for ensuring accurate laboratory test results?

Q:
Which section of the CGMP regulations requires that the analyst should ensure that only those instruments meeting established specifications are used?

Q:
Which section of the CGMP regulations requires that the analyst should ensure that only properly calibrated instruments are used?

Q:
What is the usual time requirement during the LAL-endotoxin kinetic determination?

Q:
What should the analyst do during the testing process?

Q:
What system suitability requirements may be considered?

Q:
Why could the optical density change calculation method generate OOS results?

Q:
If signal drift is a problem, then which LAL-endotoxin kinetic curves are most likely to be affected?

Q:
What should be done in the case of obvious errors?

Q:
What should be done with OOS results if clear evidence of laboratory error exists?

Q:
What should be done if unexpected results are obtained and no obvious explanation exists?

Q:
Can you list some of the obvious errors that could invalidate results?

Q:
Is it a good idea to continue with an analysis to see what results can be obtained when an obvious error is known, and that the analysis will be invalidated at a later time for an assignable cause?

Q:
What should the supervisor's responsibilities be in the case of OOS results?

Q:
What should be included in the re-examination of an immediate assessment?

Q:
What kind of transient equipment malfunction can occur in HPLC and how can it be resolved?

Q:
How should I select the procedure for an OOS failure investigation?

Q:
Who should conduct an investigation and what departments should be included?

Q:
Who should do the retesting?

Q:
What steps should be taken during the supervisor's assessment?

Q:
What should be done with OOS results when evidence of laboratory error remains unclear?

Q:
How many times can I repeat the retests?

Q:
If varying test results are obtained, and when the evidence of laboratory error remains unclear, then what may be the cause of the OOS problem?

Q:
What practices are used in the laboratory phase of an OOS investigation?

Q:
What conditions indicate retesting?

Q:
Which section of the CGMP regulations requires the establishment of specifications, standards, sampling plans, test procedures, and other laboratory control mechanisms?

Q:
What should be done if test results obtained after the predetermined number of retests are still unsatisfactory?

Q:
If I have 2 results, one original OOS result, and one of the retest results which one should be included in the batch?

Q:
How should I document my retest results?

Q:
Can you give examples when averaging can be used?

Q:
Can you give examples when averaging cannot be used?

Q:
What conditions are required for the use of averaging?

Q:
How does resampling differ from retesting?

Q:
Based on the above problems, can I use a new sampling method?

Q:
When is resampling of the batch indicated?

Q:
Do the CGMP regulations require that the acceptance and/or rejection levels be based on statistically valid quality control criteria?

Q:
How can an outlier point generate OOS results for LAL-endotoxin testing?

Q:
What determines validity for the averaging of test data?

Q:
What corrective action can you take in case of outliers?
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