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How frequently is it reasonable to experience a lab error?
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| 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. |
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What kind of transient equipment malfunction can occur in LAL-endotoxin kinetic testing and how can it be resolved?
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Why do I need to conduct an investigation if an OOS test result is obtained?
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What is the purpose of an OOS investigation?
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Who should investigate OOS?
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Which parts of the CGMP regulations apply to laboratory operations?
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Which section of the CGMP regulations specifies that products failing to meet established standards and other relevant quality control criteria will be rejected?
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How do I handle an OOT result?
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Can I ignore an OOS investigation if the rejection of a batch is based on an OOS result?
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Why is it necessary to carry out an OOS investigation if the rejection of a batch is based on an OOS result?
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Which sections of the CGMP regulations require that written records of the investigation are made, including conclusions of the investigation and follow-up?
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How do I carry out a meaningful OOS investigation?
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What should the analyst do, whenever possible, before discarding the test solution?
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When do I need to conduct a complete failure investigation?
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Who is responsible for the first course of action?
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Who has the primary responsibility for ensuring accurate laboratory test results?
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Which section of the CGMP regulations requires that the analyst should ensure that only those instruments meeting established specifications are used?
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Which section of the CGMP regulations requires that the analyst should ensure that only properly calibrated instruments are used?
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What is the usual time requirement during the LAL-endotoxin kinetic determination?
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What should the analyst do during the testing process?
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What system suitability requirements may be considered?
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Why could the optical density change calculation method generate OOS results?
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Q: |
If signal drift is a problem, then which LAL-endotoxin kinetic curves are most likely to be affected?
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What should be done in the case of obvious errors?
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Q: |
What should be done with OOS results if clear evidence of laboratory error exists?
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Q: |
What should be done if unexpected results are obtained and no obvious explanation exists?
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Q: |
Can you list some of the obvious errors that could invalidate results?
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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?
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What should the supervisor's responsibilities be in the case of OOS results?
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What should be included in the re-examination of an immediate assessment?
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What kind of transient equipment malfunction can occur in HPLC and how can it be resolved?
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How should I select the procedure for an OOS failure investigation?
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Who should conduct an investigation and what departments should be included?
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Who should do the retesting?
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What steps should be taken during the supervisor's assessment?
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What should be done with OOS results when evidence of laboratory error remains unclear?
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How many times can I repeat the retests?
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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?
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What practices are used in the laboratory phase of an OOS investigation?
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What conditions indicate retesting?
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Which section of the CGMP regulations requires the establishment of specifications, standards, sampling plans, test procedures, and other laboratory control mechanisms?
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What should be done if test results obtained after the predetermined number of retests are still unsatisfactory?
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If I have 2 results, one original OOS result, and one of the retest results which one should be included in the batch?
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How should I document my retest results?
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Can you give examples when averaging can be used?
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Can you give examples when averaging cannot be used?
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What conditions are required for the use of averaging?
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How does resampling differ from retesting?
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Based on the above problems, can I use a new sampling method?
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When is resampling of the batch indicated?
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Do the CGMP regulations require that the acceptance and/or rejection levels be based on statistically valid quality control criteria?
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How can an outlier point generate OOS results for LAL-endotoxin testing?
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What determines validity for the averaging of test data?
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What corrective action can you take in case of outliers?
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