Dear Sir, Please clarify about purging factor and safety factor in case of MACO calculation by ADE Or PDE value
@hitendrakumarshah37189 ай бұрын
The Safety factor clarification is given in the video. You can go through it - kzbin.info/www/bejne/ioikdY2jgq52p9E What is Purging factor? I am not clear. Please share details so that, I can guide you.
@music10568 ай бұрын
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
@music10568 ай бұрын
Also in APIC guideline it is mentioned that if it is not known it will be taken as 1
@music10569 ай бұрын
Dear Sir, Please clarify about Recovery factor in case of Swab limit calculation
@hitendrakumarshah37189 ай бұрын
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. kzbin.info2I_H5SsTSuQ?feature=share 2. kzbin.infozBLqRZ5DXV4?feature=share
@smarikapanwar930010 ай бұрын
Thanks
@hitendrakumarshah371810 ай бұрын
Welcome. Please share the link of learning video with your colleagues so that, they can also get benefit from this learning.
@shailendrapandey20086 ай бұрын
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?
@hitendrakumarshah37186 ай бұрын
No. First we need to validate product change over cleaning. Based on the campaagin after this validation we can perform campaign study.
@smarikapanwar930010 ай бұрын
Can you please me provide visual residue limits to incorporate cleaning validation protocol?
@hitendrakumarshah371810 ай бұрын
I suggest, you can go through this short video on CV - kzbin.info/www/bejne/sHKYqaaNh558i5o
@Bharatpithiyalive10 ай бұрын
Thank you for the knowledge.. Sir who prepared CV protocol? QA or production?