Yes You are right but i think and experienced that a number of peoples are also preferring Hindi.

Thank You

Okay i will look into it and suggest a good vendor

Limits of 0.5 and 5 micron particles revised, also clarification on viable particles monitoring limits provided, much more changes for detailed information please watch our upcoming videos and you can also read EU GMP Annexure 1, 2022

Absolutely we can measure all particle size but in Pharmaceutical Industries we only measure recommended particle size as per respective guidelines like EU GMP Annex 1, ISO 14644

Sorry I dont understand your query

For cooling of load items

Method validation is generally used in QC to develop testing methodology such as testing methods for particular products Process validation is generally used to validate processes such as Manufacturing process etc

Thank you sir

Most welcome

Thanks ✌

Okay

If your chambers pressure is more than atmospheric pressure then it is considered as positive pressure but if your chamber pressure is less than the atmospheric pressure then it is considered as negative pressure. Don't correlate it with - & +.

Thanks

Thank you

A video will be published very soon for Autoclave Qualification Acceptance Criteria

Link send kro n sir

Validation type 1) analytical method validation 2) process validation 3) equipment qualification 4)vander qualification..etc..

Don't mess up, i am explaining few parts not a complete guide here. Thank you for your queries.

Regardless the number of vents, during the lyophilization process, after the freezing step, the ice crystals sublimate via the vent(s) in the rubber stopper. It has been observed that the rate of moisture transfer from the vial increases as the cros-sectional area of the vent increase itself.

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Dhanyabad Jai Shree Ram

Its given in EU GMP Annexure 1

Its Given in EU GMP Annexure 1

So what is vacuum?

its not about writing CQP you need to identify first all relavent CQPs related to your process based on impact on the product quality and SISPQ, then write the same for CQP.

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May be

Watch this video, you will get more clarity on this. kzbin.info/www/bejne/paavhn-IqLl1opY

For that you need to do qualification of that room and based on the outcome of the result you can classify that room

Because if you do for one day, then the data of one day or two days is in doubt or questionable i.e. is it the right data or not. If we do 3 days data monitoring and evaluation of 3 days data and the data shows reliable and repeatable results.

You can also watch our video for the same on our KZbin channel

Thank you sir🙏

It depends on the agreement with the supplier, also on the nature of API and manufacturing process. Before placing an order confirm the dates of delivery.

Sure we will prepare a video on that

Glad it was helpful!