The Safety factor clarification is given in the video. You can go through it - ruclips.net/video/TWADZmMICqo/видео.html What is Purging factor? I am not clear. Please share details so that, I can guide you.
Dear Sir, I am not asking about safety factor in Case of formula in TDD. I am asking about safety factor which is given maco formula by using HBEL i. e. ADEor PDE value
Sir- Is individual rinse sample acceptable for cleaning validation or verification? Is there any guidelines requirement? Please give the reference of any.
Recovery factor is factor which we need to consider as, 100% recovery may not be possible. For detail understanding, you can go through recorded webinars - 1. ruclips.net/user/live2I_H5SsTSuQ?feature=share 2. ruclips.net/user/livezBLqRZ5DXV4?feature=share
Can we manufacture three or more batches without performing product-to-product cleaning when the campaign batch is considered the worst case during cleaning validation?
Good training sir
Thanks and welcome
Keep it up
Thank you so much
Dear Sir, Please clarify about purging factor and safety factor in case of MACO calculation by ADE Or PDE value
The Safety factor clarification is given in the video. You can go through it - ruclips.net/video/TWADZmMICqo/видео.html
What is Purging factor? I am not clear. Please share details so that, I can guide you.
Dear Sir, I am not asking about safety factor in Case of formula in TDD. I am asking about safety factor which is given maco formula by using HBEL i. e. ADEor PDE value
Also in APIC guideline it is mentioned that if it is not known it will be taken as 1
Very Helpful Sir 🙏
Thanks
Welcome Sir@@hitendrakumarshah3718
Welcome
Sir- Is individual rinse sample acceptable for cleaning validation or verification? Is there any guidelines requirement? Please give the reference of any.
Nice information given
So nice of you
Dear Sir, Please clarify about Recovery factor in case of Swab limit calculation
Recovery factor is factor which we need to consider as, 100% recovery may not be possible. For detail understanding, you can go through recorded webinars -
1. ruclips.net/user/live2I_H5SsTSuQ?feature=share
2. ruclips.net/user/livezBLqRZ5DXV4?feature=share
Can we manufacture three or more batches without performing product-to-product cleaning when the campaign batch is considered the worst case during cleaning validation?
No. First we need to validate product change over cleaning. Based on the campaagin after this validation we can perform campaign study.
Thank you Sir !!!
Most welcome!
Can you please me provide visual residue limits to incorporate cleaning validation protocol?
I suggest, you can go through this short video on CV - ruclips.net/video/zA5xsWR9IU8/видео.html
Thank you for the knowledge..
Sir who prepared CV protocol? QA or production?
@@hitendrakumarshah3718👍
Thanks
Welcome. Please share the link of learning video with your colleagues so that, they can also get benefit from this learning.