Cleaning Validation - Key Questions and Answers -II

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8 ай бұрын

#cleaning #validation #fda #pharmaceutical #pharma #pharmaguideradhakrishna
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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. Dedicated equipment required for manufacturing of potent compounds (e.g., compounds that are cytotoxic, mutagenic, or have high pharmacologic activity)?
2. Is testing rinse solution enough to support residue determinations for cleaning validation?
3, Is it necessary for companies to validate a maximum time allowed for a piece of equipment to be dirty before cleaning?
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Пікірлер: 37

@vikasgaikwad6973 8 ай бұрын

Yes

@hitendrakumarshah3718 8 ай бұрын

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@letsexplore3616 8 ай бұрын

Yes,

@hitendrakumarshah3718 8 ай бұрын

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@proogamerop5266 8 ай бұрын

Waiting for learning sir

@hitendrakumarshah3718 8 ай бұрын

Thanks for your comment

@asifandalib9226 8 ай бұрын

yes

@hitendrakumarshah3718 8 ай бұрын

Thank you for your kind comment confirmation

@emmanuelnkiligi889 8 ай бұрын

Sir does a facility manufacturing mono product such as oral rehydration salt ( ORS) need to perform or conduct cleaning validation

@hitendrakumarshah3718 8 ай бұрын

cleaning validation is required.

@emmanuelnkiligi889 8 ай бұрын

Sir does USFDA allow or approves also Beta lactam products manufactured in the same facility with other products as it has approved for potent products like cytotoxic products

@hitendrakumarshah3718 8 ай бұрын

Yes, definitely. Only thing is, you need to put more controls while manufacturing of these products.

@shailendrapandey2008 4 ай бұрын

Is continuous product-to-product cleaning a must during cleaning validation studies in between three consecutive batches, or can we manufacture many batches in between product-to-product cleaning?

@hitendrakumarshah3718 3 ай бұрын

We need to validate product change over cleaning. In this situation, after manufactuirng you need to conduct the study. If there is not other batch of the same product for manufacturing, you can follow cleaning and perform study and after ensuring you can go for other product manufacturing. Hope this will solve your doubt.

@tirupatibabukilari4335 8 ай бұрын

Hello sir thanks in advance actually i have asked this question at WhatsApp but as per your suggestion i have committed here! As per USFDA Guidence Scale batch comes under which stage, exhibit batches comes under which stage, Commercial process validation batches comes under which stage

@hitendrakumarshah3718 8 ай бұрын

Scale up batch is nothing but increase in batch size in GMP environment. The exhibit batches are study batches. After study, the data is submitted to authorities for approval. After approval from them, commercial batches are manufactured.

@Bharatpithiyalive 7 ай бұрын

Thank you sir For awesome explanation Please please help to confirmed in cleaning validation only rinse and swab test is enough? What is acceptance criteria of both how to calculated MACO or risk factor

@chiareddy7468 8 ай бұрын

I have a question is FAT and SAT are applicable for only equipment is it his not applicable for software application

@hitendrakumarshah3718 8 ай бұрын

FAT and SAT is applicable for both - Equipment and software. It is considered as CE (Computerised Equipment). You can go through the learning of PLC validation for more details - kzfaq.infoE1jT_QbPEx8?si=4uVctfCIbiOIwbWs

@Ultra_art711 8 ай бұрын

Recently PDE value shall we consider 10 mcg or 1.5 mcg ?

@hitendrakumarshah3718 8 ай бұрын

The PDE should be calcuated by toxicologist. The value shared should be followed.

@tirupatibabukilari4335 8 ай бұрын

Sir what is recovery minimum %during method development

@hitendrakumarshah3718 8 ай бұрын

Normally not less than 70% recovery is expected.

@my_pride35 8 ай бұрын

Can you please take a session for usfda virtual manufacturing facility.

@hitendrakumarshah3718 8 ай бұрын

Sure. But need to know, how many participants are interested for this session.

@my_pride35 8 ай бұрын

Okay. How can we get that numbers.

@Ultra_art711 8 ай бұрын

In sterile facility cleaned hold time required

@hitendrakumarshah3718 8 ай бұрын

Yes

@Bharatpithiyalive 7 ай бұрын

Sir i want to know about cleaning equipment hold time study

@hitendrakumarshah3718 5 ай бұрын

You can go through the below links - 1. kzfaq.info2I_H5SsTSuQ?feature=share 2. kzfaq.infozBLqRZ5DXV4?feature=share

@vikramchoudhary2913 8 ай бұрын

Vikram choudhary

@hitendrakumarshah3718 8 ай бұрын

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@user-qj8pl8zf8s 8 ай бұрын

Rajni Jha

@hitendrakumarshah3718 8 ай бұрын

Thank you for your comment confirmation

@Bharadwaj22varma 2 ай бұрын

Hi sir, what are the solvents that can be used for swabbing other than water?

@my_pride35 8 ай бұрын

Csv

@hitendrakumarshah3718 8 ай бұрын