Out of specification (OOS) and Out of trend (OOT) in pharmaceutical industry l important questions скачать в хорошем качестве

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

----------------------------------------------------------------------------------------------- Out of specification (OOS) and Out of trend results (OOT) in pharmaceutical industry l Basic and important questions ----------------------------------------------------------------------------------------------- Go to below playlists and search for a topic you want: 1. QMS - Quality Management System in Pharmaceutical industry :    • QMS - Quality Management System in Pharmac...   2. QA- Quality assurance in Pharmaceutical industry. :    • QA- Quality assurance in Pharmaceutical in...   3. QC - Quality Control in Pharmaceutical industry :    • QC - Quality Control in Pharmaceutical ind...   4. OSD - Tablet Manufacturing in Pharmaceutical industry :    • OSD - Tablet Manufacturing in Pharmaceutic...   5. Injectable processing - Injectable processing or Sterile dosage formulation :    • Injectable processing - Injectable process...   ----------------------------------------------------------------------------------------------- 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? ----------------------------------------------------------------------------------------------- Keywords to find this video: change control in pharmaceutical industry,deviation and change control in pharma,change control in pharma,oot in pharmaceutical industry,oos investigation in pharmaceutical industry,oos in pharmaceutical in hindi,oos in pharmaceutical,out of specification in pharma,in pharma industry,#oos in pharma,capa in hindi,pharma industry,oos result in pharma,pharmaceuticals,pharma industry explained in telugu,out of specification in pharmaceuticals,oos in industry ----------------------------------------------------------------------------------------------- Copyright disclaimer: “Any illegal reproduction of this content will result in immediate legal action.”