Out Of Specification (OOS) Investigation Phase Ia & Phase Ib (MHRA)
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- Опубликовано: 24 авг 2024
- #oos #investigation #pharma #interview
Out Of Specification (OOS) Investigation Phase Ia & Phase Ib (MHRA)
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I can’t thank you enough
Nice explaination
So nice please upload the phase 2
Sir, please explain phase-II and phase-III also 🙏
TQ sir ... Nice explained
Super sir, thank you very much, I have learnin more from thi
Please make a video on preliminary impact assessment during investigation
Good information sir
nice
खुपच छान सर... धन्यवाद...
Hi sir, can you please share OOS phase 2 and 3 investigation presentation also.
thank you
Obvious errors:
Dilution error
Weighing error
Standard may degrade (standard area) when compare to previous result
Correct method and specifications are followed or not that's also considered in Phase-1A
System suitability failure is also obevios errors
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Can you do video about validation processes
If solutions are not stable, how to find the analyst mistake in preparation?
Thanks so much
How wavelength is obvious error, if wavelength wrong is used for analysis, area of standard can not match with previous analysis then why we proceed further,
If we proceed further then oos can not happen 99% because wavelength is same through out analysis also during validation we perform plus minus wavelength robustness parameter
Hi, Have done phase II and III?
Sir , How to investigate hold time OOS
sir in hypothesis Re-test y wrong stock preparation included i think if weight wrong taken means phase-1a only we came to know right
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