Cleaning Validation - Key Questions and Answers - III

[@ramakrishnaguttula7941]

Good training sir

[@hitendrakumarshah3718]

Thanks and welcome

[@mayurkale5357]

Keep it up

[@hitendrakumarshah3718]

Thank you so much

[@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

[@vinayakdumka5247]

Nice information given

[@hitendrakumarshah3718]

So nice of you

[@Training-rt3ng]

Very Helpful Sir 🙏

[@hitendrakumarshah3718]

Thanks

[@Training-rt3ng]

Welcome Sir@@hitendrakumarshah3718

[@Training-rt3ng]

Welcome

[@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.

[@mayurkale5357]

Sir- Is individual rinse sample acceptable for cleaning validation or verification? Is there any guidelines requirement? Please give the reference of any.

[@hitendrakumarshah3718]

what do you mean by individual? Rinse will be for specific equipment/accessories. Please elaborate your question.

[@mayurkale5357]

I am saying, that any equipment is only a rinse sample sufficient? Without taking a swab can I take a rinse sample only?

[@hitendrakumarshah3718]

@@mayurkale5357 It depends on the type of equipment. Ideally, Only one type of sampling is not accepted. You can make use of multiple sampling technique during entire validation study.

[@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

[@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👍

[@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.