Great efforts ,Because of your channel my knowledge is increasing I have one question about deviation is that which type of deviation required investigation for major or critical thanks in advance
Thanks for comment 👍 Ideally we should investigate all type of deviations. Deviation investigation should be compulsory for all category like minor, major and critical for following reasons, 1. To perform impact assesemt of batches executed and batches to be executed. 2. To identify root cause and make necessory corrective and preventive actions to avoid repeat occurence. 3. To track and monitor QMS control over manufacturing and analytical processes.
The diagram was popularized by Kaoru Ishikawa, a Japanese quality control expert, which is why it's also commonly known as an Ishikawa diagram. So, in short, there is no difference between a Fishbone diagram and an Ishikawa diagram - they're just two different names for the same tool!
Hello Mam, Below three guidelines were referred while creating the presentation, 1. Deviation Basic concepts: ICH Q10: 2008 2. Deviation classification: WHO Guideline on Quality Risk Management Annex 2 3. Question related to OOS investigation: Guidance for industry for investigating OOS test results for pharmaceutical production (October 2006) Additionally, few points were included based on the cumulative review of few USFDA’s audit observations shared on official site and followed established industrial deviation handing practices.
Thanks for information.
Just wants add here that 'Fishbone diagram, Ishikawa and 6M' all are same.
Yes. Agree with you. Thanks for comment 👍
Great efforts ,Because of your channel my knowledge is increasing I have one question about deviation is that which type of deviation required investigation for major or critical thanks in advance
Thanks for comment 👍
Ideally we should investigate all type of deviations. Deviation investigation should be compulsory for all category like minor, major and critical for following reasons,
1. To perform impact assesemt of batches executed and batches to be executed.
2. To identify root cause and make necessory corrective and preventive actions to avoid repeat occurence.
3. To track and monitor QMS control over manufacturing and analytical processes.
Sir if you don't mind will you pls explain in Telugu language also
Ok. I will try to do.
bro can you make the video of difference between sterilization and sentization..plz..
Sure. I will do it 👍
Kindly request to send sir please give information on ampule and vial filling machine validation or qualification
Ok
Difference between fish bone and ishikawa?
The diagram was popularized by Kaoru Ishikawa, a Japanese quality control expert, which is why it's also commonly known as an Ishikawa diagram.
So, in short, there is no difference between a Fishbone diagram and an Ishikawa diagram - they're just two different names for the same tool!
Bro can you make the vedio of NVPC
Thanks for suggestion. I started working on NVPV
Sir mfg tank sip validation ka video bnao plz
Ok 👍
Nice
Thanks
Hi sir...can u please give pdf copies of topics..it will be helpful for me
You can download video
Can u plz send me the question PDF
Mail me on Yogpharma409@yahoo.com
Can u provide the reference for this ppt
There are multiple documents referred. Please tell me point for which reference required.
@@PharmGrow thanks for the reply. Wil it be possible to give ref for all documents
I need time to work on this. I will definitely reply here.
Thanks a lot..
Hello Mam,
Below three guidelines were referred while creating the presentation,
1. Deviation Basic concepts: ICH Q10: 2008
2. Deviation classification: WHO Guideline on Quality Risk Management Annex 2
3. Question related to OOS investigation: Guidance for industry for investigating OOS test results for pharmaceutical production (October 2006)
Additionally, few points were included based on the cumulative review of few USFDA’s audit observations shared on official site and followed established industrial deviation handing practices.
Sir please give this question pdf
Please Comment your mail ID or contact no.