Cleaning Validation - Key Questions and Answers

Cleaning Validation - Key Questions and Answers - III

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Күн бұрын

#validation #pharmaceutical #fda #pharma #who #qualitycontrol #quality
#cleaning #validation
This video is prepared to make all of you understand key expectations from different guidelines. For that purpose, 3 questions are identified every week and answered in line with current guidelines.
In this video, the questions answered are;
1. Do we need to perform validation of the cleaning process for product non-contact surfaces?
2. As we know that, process validation is done in three stages - Process design, process qualification, and continued process verification.
Whether the cleaning validation also to be done in three stages?
3. Only QA is responsible for approval of the cleaning validation report?
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Пікірлер: 26

@ramakrishnaguttula7941 3 ай бұрын

Good training sir

@hitendrakumarshah3718 3 ай бұрын

Thanks and welcome

@mayurkale5357 7 ай бұрын

Keep it up

@hitendrakumarshah3718 7 ай бұрын

Thank you so much

@vinayakdumka5247 7 ай бұрын

Nice information given

@hitendrakumarshah3718 7 ай бұрын

So nice of you

@AUDITS-wm2dg 7 ай бұрын

Thank you Sir !!!

@hitendrakumarshah3718 7 ай бұрын

Most welcome!

@smarikapanwar9300 7 ай бұрын

Thanks

@hitendrakumarshah3718 7 ай бұрын

Welcome. Please share the link of learning video with your colleagues so that, they can also get benefit from this learning.

@Training-rt3ng 7 ай бұрын

Very Helpful Sir 🙏

@hitendrakumarshah3718 7 ай бұрын

Thanks

@Training-rt3ng 7 ай бұрын

Welcome Sir@@hitendrakumarshah3718

@Training-rt3ng 7 ай бұрын

Welcome

@music1056 6 ай бұрын

Dear Sir, Please clarify about Recovery factor in case of Swab limit calculation

@hitendrakumarshah3718 6 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. kzfaq.info2I_H5SsTSuQ?feature=share 2. kzfaq.infozBLqRZ5DXV4?feature=share

@music1056 6 ай бұрын

Dear Sir, Please clarify about purging factor and safety factor in case of MACO calculation by ADE Or PDE value

@hitendrakumarshah3718 6 ай бұрын

The Safety factor clarification is given in the video. You can go through it - kzfaq.info/get/bejne/ir1xd72esq-noaM.html What is Purging factor? I am not clear. Please share details so that, I can guide you.

@music1056 6 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

@music1056 6 ай бұрын

Also in APIC guideline it is mentioned that if it is not known it will be taken as 1

@shailendrapandey2008 4 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?

@hitendrakumarshah3718 3 ай бұрын

No. First we need to validate product change over cleaning. Based on the campaagin after this validation we can perform campaign study.

@smarikapanwar9300 7 ай бұрын

Can you please me provide visual residue limits to incorporate cleaning validation protocol?

@hitendrakumarshah3718 7 ай бұрын

I suggest, you can go through this short video on CV - kzfaq.info/get/bejne/sKdlq9aIt5-thWw.html

@Bharatpithiyalive 7 ай бұрын

Thank you for the knowledge.. Sir who prepared CV protocol? QA or production?

@smarikapanwar9300 7 ай бұрын

@@hitendrakumarshah3718👍