In Hindi, Area Classification, Non-viable Particle Count
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- Опубліковано 7 вер 2024
- What is Grade A, B, C, D? What is Area Clarification? हिंदी में, #aseptic #quality @PHARMAVEN #gmp
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Few Insights on How to be Successful in Regulatory Inspection in Pharmaceutical Industry, Mainly on Personnel Practices and Procedures
Few Insights on How to be Successful in Regulatory Inspection in Pharmaceutical Industry, Mainly on Personnel Practices and Procedures
Sir please make video on cleaning validation
Good information sir
Thank you sir..
Thank you sir
Engineering ke liye bhi vedio banaye.
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Thank you Sir!
Kon si guidelines me sir daily karte hai
sir aap1 video batch manugacturiing ke bare me video bano pls injectable
Problems and Solutions, Injectables Batch Manufacturing #manufacturing #fda #aseptic #sterile #gmp
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Sir, please make video on new stability chamber qualification.
Sir passbox LAF cabinet ko rest or operation me kis grade me NVPC krna chahiye
It should be equal to cleaner grade of area where it opens
Table A.1 is applicable for non-viable locations or both viable & non-viable both ?
Only non viable
Can we use DI water in autoclave for steam generation
Does your autoclave is with in built steam generation?
Sir satick condition me koi activity nahi hoga but agar ham a grade me em kar rahe hai to b grade me ham activity kar sakte hai
Yes
When you are working under Grade A, you can also work in grade B but all activities under Grade A are aseptic simulation and must be done in media fill
What if take the measurements in cubic feet ? Will the sampling time be reduced?
I have a shorts video on that
Very useful video sir , I have a question I understood about the critical points as you had described it already in this video, so sir what would be the non critical sampling location/points? Thanks
Non critical locations are those where there are no open sterile containers, no interventions, no fillings or stoppering is done,
For example, after vial is sealed, there is no exposure of product to open atmosphere hence that section is not critical
In area, where there is no man material movement, material storage , for example, corners of room, locations near filling machine where there is no intervention or operator activity are non critical locations
We don’t have to do any monitoring on non critical locations
Great , thanks so much sir for the reply.. it was very helpful
I have also prepared video for that