Cleaning Validation - Key Questions and Answers -II

#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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[@proogamerop5266]

Waiting for learning sir

[@hitendrakumarshah3718]

Thanks for your comment

[@emmanuelnkiligi889]

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

[@hitendrakumarshah3718]

cleaning validation is required.

[@letsexplore3616]

Yes,

[@hitendrakumarshah3718]

Thank you for your comment confirmation

[@vikasgaikwad6973]

Yes

[@hitendrakumarshah3718]

Thank you for your comment confirmation

[@emmanuelnkiligi889]

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]

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

[@shailendrapandey2008]

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]

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.

[@chiareddy7468]

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

[@hitendrakumarshah3718]

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 - czcams.com/users/liveE1jT_QbPEx8?si=4uVctfCIbiOIwbWs

[@my_pride35]

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

[@hitendrakumarshah3718]

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

[@my_pride35]

Okay. How can we get that numbers.

[@tirupatibabukilari4335]

Sir what is recovery minimum %during method development

[@hitendrakumarshah3718]

Normally not less than 70% recovery is expected.

[@asifandalib9226]

yes

[@hitendrakumarshah3718]

Thank you for your kind comment confirmation

[@Ultra_art711]

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

[@hitendrakumarshah3718]

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

[@Ultra_art711]

In sterile facility cleaned hold time required

[@hitendrakumarshah3718]

Yes

[@tirupatibabukilari4335]

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]

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]

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

[@Bharatpithiyalive]

Sir i want to know about cleaning equipment hold time study

[@hitendrakumarshah3718]

You can go through the below links -
1. czcams.com/users/live2I_H5SsTSuQ?feature=share
2. czcams.com/users/livezBLqRZ5DXV4?feature=share

[@vikramchoudhary2913]

Vikram choudhary

[@hitendrakumarshah3718]

Thank you for your comment confirmation

[@user-qj8pl8zf8s]

Rajni Jha

[@hitendrakumarshah3718]

Thank you for your comment confirmation

[@Bharadwaj22varma]

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

[@my_pride35]

Csv

[@hitendrakumarshah3718]

OK