Cleaning Validation - Key Questions and Answers - III

#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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[@ramakrishnaguttula7941]

Good training sir

[@hitendrakumarshah3718]

Thanks and welcome

[@mayurkale5357]

Keep it up

[@hitendrakumarshah3718]

Thank you so much

[@vinayakdumka5247]

Nice information given

[@hitendrakumarshah3718]

So nice of you

[@AUDITS-wm2dg]

Thank you Sir !!!

[@hitendrakumarshah3718]

Most welcome!

[@smarikapanwar9300]

Thanks

[@hitendrakumarshah3718]

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

[@Training-rt3ng]

Very Helpful Sir 🙏

[@hitendrakumarshah3718]

Thanks

[@Training-rt3ng]

Welcome Sir@@hitendrakumarshah3718

[@Training-rt3ng]

Welcome

[@music1056]

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

[@hitendrakumarshah3718]

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

[@music1056]

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

[@hitendrakumarshah3718]

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.

[@music1056]

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]

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

[@shailendrapandey2008]

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]

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

[@smarikapanwar9300]

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

[@hitendrakumarshah3718]

I suggest, you can go through this short video on CV - kzbin.info/www/bejne/sHKYqaaNh558i5o

[@Bharatpithiyalive]

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

[@smarikapanwar9300]

@@hitendrakumarshah3718👍