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Process Validation - Key Questions and Answers 1
Рет қаралды 977
Күн бұрын#process #validation #ppq #process performance #interview #pharmaceutical
During this session, you will come to know the answers to the below questions. The answers are explained with reference to the different regulatory guidelines.
1. Is it mandatory that, the suppliers of critical raw and packaging materials should be qualified before manufacturing of validation batches?
2. During commercial process validation, is it required to compare, evaluate, and report the validation batch data with the Test /exhibit/submission batch data?
3. Can we follow the bracketing approach during process validation studies?
If you need further clarification guideline reference or further thoughts, please feel free to contact me.
For detailed Equipment/Instrument Qualification - kzfaq.info...
For detailed process validation - kzfaq.info...
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@cricketanalysisbyankit5170 9 ай бұрын
Feel More Confident after watching your videos.. Thank you sir .
@hitendrakumarshah3718 8 ай бұрын
Nice to hear this. Please share the link of learning video with your colleagues so that, they can also get benefit from this learning.
@hitendrakumarshah3718 9 ай бұрын
Thank you for your LIKE Thumb👍
@hitendrakumarshah3718 9 ай бұрын
Good evening all of you
@Ultra_art711 9 ай бұрын
Yes All RM and PM qualified during Vendor Qualification.
@hitendrakumarshah3718 8 ай бұрын
Nice
@maheshsaglawe 9 ай бұрын
Good evening sir
@hitendrakumarshah3718 9 ай бұрын
Good evening !!!
@maheshsaglawe 9 ай бұрын
What is Difference between scale batch,exhibit batch, standarisation batch ?
@hitendrakumarshah3718 7 ай бұрын
Scale up batch is for manufacturing of batch with mfg batch size suitable for mfg site. This batch is taken when in R&D, batch is manufacured with less batch size. The standardisation batch and scale up batch can be taken as synonymously as, during scale up, the operating parameters are standardised. Exhibit batch is batch where PV, stability and complete batch is evaluated and submitted in the dossier.
@Bharatpithiyalive 9 ай бұрын
BMR filling required in VALIDATION beaches?
@hitendrakumarshah3718 8 ай бұрын
Yes. Validation batches are normal batches. All documentation should be followed.
@Bharatpithiyalive 8 ай бұрын
Ok... Thank you sir In WHO GMP audit for topical ointments external preparation plant.... Before validation batches which key documents required i.e. manufacturing of clobetasol there is no R&D or F&D required we do only process developed.... In that case which process we can do before commercial batches
@Ultra_art711 9 ай бұрын
Bio batch report not available with plant level instead of that can we compare pre exhibit batch with routine PV batches
@hitendrakumarshah3718 8 ай бұрын
This case needs to be evaluated in detail. I suggest to raise deviation and evalute - What are diff in these batches, why report is not availble, any variabilities etc etc/
@milindpatil9673 9 ай бұрын
Very nice sir. Sir ppt please
@hitendrakumarshah3718 8 ай бұрын
PPT will not help you. Because, along with the details, I discussion many things. Also, I am having PPT only on the day of training session. After that, I do not have.
@Ultra_art711 9 ай бұрын
Bracketing approach can we use 10fold factor
@hitendrakumarshah3718 8 ай бұрын
Your question is not clear. Can you please elaboarate the question.
@Ultra_art711 8 ай бұрын
If any process validated with the batch size of 100 kg, after that if batch size increased upto 500 kg, shall we use 10 fold X criteria to not to perform revalidation upto 1000 kg , after 1000 kg can be revalidate. Any guideline support , pl. Help.
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