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Out of specification (OOS) and Out of trend results (OOT) in pharmaceutical industry l Basic and important questions
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Questions covered:

1. What is difference between OOS and OOT results?
2. What are the different phases of OOS / OOT investigation ?
3. What is Obvious error investigation ?
4. What is hypothesis testing ?
5. Is it mandatory to perform investigation if batch under investigation is to be rejected?
6. Which are the commonly used investigation tools for OOS / OOT investigation?
7. What additional testing can be done in the Phase-II investigation ?
8. Is the repeat testing till results come into specification criteria is allowed?
9. Can we use the result outcomes from additional testing for batch release ?
10. What should be the action plan in case of laboratory or sampling error not confirmed ?
11. Can we reject batch based on the initial OOS results only?
12. What are basic requirements for the OOS / OOT investigation expected from USFDA ?
13. Why number of laboratory errors should be minimum ?
14. It is required to raise OOS if OOS result is observed during periodic testing (in-process) testing during manufacturing ?
15. It is required to raise OOS if OOS result is obtained during Method transfer, analyst qualification or vendor evaluation samples?
16. What procedure shall be followed for additional sampling and testing ?
17. What are the commonly used checkpoints in Phase-I investigation i.e. laboratory investigation ?
18. What key points are covered during Phase-II investigation ?
19. What should be the mandatory part of the manufacturing investigation ?
20. What are the basic requirements for performing retesting ?
21. What we should check during review of sampling and storage review as a part of OOS investigation?
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