Process Validation - Key Questions and Answers 1
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- Опубліковано 7 лис 2023
- #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.
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Good evening all of you
Yes All RM and PM qualified during Vendor Qualification.
Nice
Good evening sir
Good evening !!!
Bio batch report not available with plant level instead of that can we compare pre exhibit batch with routine PV batches
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/
What is Difference between scale batch,exhibit batch, standarisation batch ?
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.
BMR filling required in VALIDATION beaches?
Yes. Validation batches are normal batches. All documentation should be followed.
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
Very nice sir. Sir ppt please
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.
Bracketing approach can we use 10fold factor
Your question is not clear. Can you please elaboarate the question.
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.