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OOS

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Q:	When is resampling of the batch indicated? A: A resampling of the batch should be conducted if the investigation shows that the original sample was not representative of the batch. (Note: in some cases, when all data have been examined (e.g., widely varied results obtained from several aliquots of the original composite/after determining there was no performance error made in the analysis), it may be concluded that the original sample was improperly prepared and was therefore not representative of the batch (§211.160(b)(3)).
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 frequently is it reasonable to experience a lab error?
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:	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?