Sir, after completion of leak test, will check the tablets complete portion so for that purpose tablets are de blistered. In such case how leaktested sample will mix with good product.
Sir, very good video. Thank you. Have two question, if due to human error one of the controlled document got misplaced/missing and not able to find. What should be the criticality ( should it be minor? As it won't impact product or should it be major as even though the product is not impacted but a controller document is missing. It won't affect quality attribute (SISPQ). And root cause is negligence on the personnel's part in handling.? Please advise . Thank you
As per ALCOA++ - Available is the requirement. If the document is not available during review or audit, it may be considered as DI. This should be treated as critical. Further "Negligence" is not root cause. Why negligence? need to evaluated.
Sir, I listen human error session now, it's very useful to us and what you explained about human errors it is exactly right. However, I have one question that, if repeated errors were occurred for instrument by human, what justification is required to close the same in investigation without separate capa initiation. However, in guidelines mentioned that, if repeated by person it will be give awareness training. However, if repeated same causes it is acceptable only the training.
Good Question. If there is repeated error by the person, you please follow this recorded session in detail. You will get idea about how to investigate the human errors. Also, you please go up to last as, in the last, I have answered many questions raised by the participants. You will get answer from the same video. Just it is required for you to go through this recorded webinar completely and slowly.
sir i have 1 question regarding last to last session on data integity on microbiology regarding scribe .if scribe made mistake during noting the work of doer who will gonna make sign in that mistake???? scribe or doer???
As per GMP, the errror should be acknoledged, cut it, correct it and sign it. It can be either signed by scribe at the time of entry itself or by doer once during review the error is identified.
Sir so many companies recruiting intermediate (plus 2) students I was asked one person he said social corporate responsibility please tell is it correct or not if correct wt type of analysis is matching to them
As per the GMP requirement, the personnel should have adequate education, training, experiance or any combination thereof. You can ensure compliance by following this rule.
Very informative thanks sir for great session
session is useful and the knowledge it provides gives us the idea of know how of actual human errors
Thank you so much for your kind words...
indepth investigation strategy explained, great 👍
Thank you !!!
Sir, after completion of leak test, will check the tablets complete portion so for that purpose tablets are de blistered. In such case how leaktested sample will mix with good product.
This is just an example , where the possibility of error. We should not use them.
Sir, very good video. Thank you. Have two question, if due to human error one of the controlled document got misplaced/missing and not able to find. What should be the criticality ( should it be minor? As it won't impact product or should it be major as even though the product is not impacted but a controller document is missing.
It won't affect quality attribute (SISPQ). And root cause is negligence on the personnel's part in handling.? Please advise .
Thank you
As per ALCOA++ - Available is the requirement. If the document is not available during review or audit, it may be considered as DI. This should be treated as critical. Further "Negligence" is not root cause. Why negligence? need to evaluated.
Thank you sir ,sharing your knowledge and spending time for us
Welcome. If you have any questions, please feel free to put in comment section.
Sir, I listen human error session now, it's very useful to us and what you explained about human errors it is exactly right. However, I have one question that, if repeated errors were occurred for instrument by human, what justification is required to close the same in investigation without separate capa initiation. However, in guidelines mentioned that, if repeated by person it will be give awareness training. However, if repeated same causes it is acceptable only the training.
Good Question. If there is repeated error by the person, you please follow this recorded session in detail. You will get idea about how to investigate the human errors. Also, you please go up to last as, in the last, I have answered many questions raised by the participants. You will get answer from the same video. Just it is required for you to go through this recorded webinar completely and slowly.
sir i have 1 question regarding last to last session on data integity on microbiology regarding scribe .if scribe made mistake during noting the work of doer who will gonna make sign in that mistake???? scribe or doer???
As per GMP, the errror should be acknoledged, cut it, correct it and sign it. It can be either signed by scribe at the time of entry itself or by doer once during review the error is identified.
Yes
Thanks for comment
sir please send the file related to this session because at that time my net was slow so i was not able to download that..
aryan pant we.tl/t-82zVfcLlFJ
Please use this link
Really your grate sir
Thank you. Please Keep Learning !!!
Sir so many companies recruiting intermediate (plus 2) students I was asked one person he said social corporate responsibility please tell is it correct or not if correct wt type of analysis is matching to them
As per the GMP requirement, the personnel should have adequate education, training, experiance or any combination thereof. You can ensure compliance by following this rule.
AMEN GOD GOOD
Thanks
Ok
Thanks