Out of specification (OOS) and Out of trend (OOT) in pharmaceutical industry l important questions

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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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Go to below playlists and search for a topic you want:
1. QMS - Quality Management System in Pharmaceutical industry : • QMS - Quality Manageme...
2. QA- Quality assurance in Pharmaceutical industry. : • QA- Quality assurance ...
3. QC - Quality Control in Pharmaceutical industry : • QC - Quality Control i...
4. OSD - Tablet Manufacturing in Pharmaceutical industry : • OSD - Tablet Manufactu...
5. Injectable processing - Injectable processing or Sterile dosage formulation : • Injectable processing ...
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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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[@nayakdhaval1210]

Hello sir Can you make the videos of IPQA work related means total activity of in process quality assurance person if you can then please..

[@PharmGrow]

Ok. I will do it. 👍

[@nayakdhaval1210]

@@PharmGrow because it too much help to clear the interview..

[@talhakhan3747]

Please can you provide pdf of all QA Slides? It would be very helpful for me to download all the material and then easy to memorize and understand the concepts

[@PharmGrow]

Mail me on [e-mail]

[@vijay18panneer]

Bro for your information usfda OOS guidelines may-2022 revision-2 released...

[@PharmGrow]

Thanks for update