Видео

Please explains change control risk assessment, impact assessment and action items for change in excipient, API vendor Change in equipment Change in area Change in location / site Introducing new product Change in batch size Change in software

Super

Sir, will you please answer my below question. Why ampoule products require sterilization and vial products for depyrogenation. Can we use depyrogenation tunnel for ampoule product

Have you made any vedio on injectable machines from engineering point of view of totally related to technical issues and maintenance.

Sir plz confirm that Dwell time and fd value is same in tunnel validation

Very helpful voor video

Thanks a lot

Can you share xls file download link

Thanks continue

Very department expansion good

Can you clarify this from EU Volume 4 annex 1 as I am confused how to include load dryness by visual inspection in SOP or part of line clearance? 8.56 The items to be sterilised, other than products in sealed containers, should be dry, packaged in a protective barrier system which allows removal of air and penetration of steam and prevents recontamination after sterilisation. All loaded items should be dry upon removal from the steriliser. Load dryness should be confirmed by visual inspection as a part of the sterilisation process acceptance.

very good understanding

Very informative..... well explained.....

Very informative content 👌 👏

Its informative

There is one more possibility of introducing H2O2 by turbulent flow through nozzle directly to the chamber, in IMA machine we had qualified.For your information

Knowledgeable 📸 video sir ji

Sir please explain about nitrosamine risk assessment

Tone is controlled very well. Try to show CC document also

As high pressure will be there in infeed zone of filling machine? Possible for air turbulence?

Is that air from hot zone can go to cool zone? Possibility for Contamination?

Great work done. Thanks for the presentation 👍

Nice presentation

Good

🤷 𝓹𝓻𝓸𝓶𝓸𝓼𝓶

The book "300 Questions About Drug Product Manufacturing" on A. did help me a lot!

Good explanation sir my dout compounding main checking points and critical observation Kya Kya hey mey ipqa mey job karahun

Thank you so much Palas, you videos are very informative

sir please explain about Risk assessment on new facility creation

Thank you

Neat n simple explanation... Thank you

dear palash , very good clarity on subject , good luck for your journey

Gracias, greetings from Perú

Sir please explain in Hindi also ..

Hindi me video banaye

Please Hindi so everyone can learn sir 🙏

Please tell about Fh value limit for depyrogenation at 320

Very helpful in short time video. Thanks sir

Very useful information you are sharing 👌🏻👌🏻👌🏻

Thanks Palash for this presentation Request for detail presentation on media fill simulation

very detailed explanation!

Also in the previous video you mentioned that cleaning of primary packaging materials such as vials is happened in the grade D area whereas now you're saying it's happening in the Grade C area? Can you confirm where it happens?

I just wanted to know - Filteration of the Drug product which is in the holding vessel is happening in the Grade C area with Laminar air flow Grade A? - Terminal sterilization And filteration and sterilization of Drug product which is in the holding vessel is happening in the Grade B area with Grade A laminar air flow - Asceptic sterilization Is this correct?

Dear Mentor,Thank you so much,

Very well.

How to evaluate & fix Ramp time & Soak time either in primary or secondary drying. Pl. Clarify it sir.

Would you please share the relation between D value and F(physical) vlue?

What reason behind maintain 300 degrees only.

Thankyou very fruitful training 😊