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Question & Answer from OOS guideline USFDA

Question & Answer from OOS guideline USFDA

Question number: 1) In which section of 21 CFR 211 it is written that I need to conduct an investigation if an OS test result is obtained ?
Answer: Is an investigation is required by FDA regulation as mentioned in the section 211.192 Question Number: 2) What is the purpose of an OS investigation ?
Answer: To determine the cause of the OS the result.
Question number: 3) Who should investigate OOS ?
Answer: Investigation should be done by both manufacturing companies as well as contract laboratories.
Question number:4) Which part of CGMP regulation apply to laboratory operations?
Answer: part 211 sub-part I for laboratory controls and sub-part J stands for records and reports Question number: 5 )Which section of CGMP regulations specify is that product failing to made established standard and other relevant quality control criteria will be rejected ?
Answer: It is clearly written in the section 211.165(f) if your product is failing you have to reject it is clearly written in this section. 
Question number:6) How do I handle an OOT result? 
Answer: If you are obtaining OOT result you have to follow the same approach as you are following the approach for OOS investigation.
 Question number: 7) Can I ignore an OOS investigation if the rejection of a batch is based on an OOS result ?
Answer; No batch rejection does not negate the need to perform the investigation. 
Question question number: 8) Why it is necessary to carry out an OOS investigation if the rejection of a batch is based on an OOS result ?
Answer: To determine if the result is associated with other batches of the same drug product or other products.
Question: 9) Which section of CGMP regulations require that written record of investigation are to be made including conclusions of the investigation and follow-up?
 Answer It is clearly written in Section two 211.192
Question number: 10) Wow do I carry out the meaningful OOS investigation.?
Answer:A meaningful OOS investigation should be thorough, timely, unbiased, well documented and scientifically sound.
Question number: 11) What should analysts do before discarding that test solution.?
Answer: Very very important answer the question is that and initial assessment should be done analysts should check whether the results are passing or failing so that he can use the solutions for the hypothesis purposes so analyst should not discard the solution before ensuring the results. Question number: 12) Who is responsible for first course of the action?
Answer: Analyst
Question number: 13) Who has the primary responsibility for ensuring accurate laboratory test results?
 Answer: Analysts
Question number: 14) What should the analyst do during the testing process ?
Answer: The analysts should be aware of the potential problem that can occur during the testing process and should watch for problems that create OOS.
Question number:15) Which section of CGMP regulations require that the analyst should ensure that only those instruments meeting established specifications are to be used for analysis?
 Answer: Section number 211.160(b)(4)
 Question number:16) Which section of CGMP regulation required that the analyst should ensure that the only properly calibrated instruments are used for the analysis ?
Answer That is it is clearly written in Section number 211.160(b)(4) that you have to use the calibrated instruments.
Question number: 17) What should be done if unexpected results are obtained and no obvious explanation exists ?
 Answer Test preparation should be retained, analysts should inform a supervisor and an accuracy assessment should be started immediately when you are obtaining unexpected results these are the steps which we have to follow.
Question number: 18) Can you list some of the obvious errors that could invalidate results ?
 Answer: Obvious errors like the spilling of the sample in complete transfer wrong.
Question number: 19) What should be done in case of obvious errors simple ?
Answer The analysts should immediately document the occurrence or the observation of the obvious errors.
 Question Number:20) Is it a good idea to continue with an analysis to see what results can be obtained when obvious an error is known and that the analyst or that the analysis will be invalidated at a later time for an assignable cause?
Answer No, analysts should not knowingly continue any analysis if they expect that results are cool to invalidate.


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