Smoke Study Related 483s and Warning Letters ​⁠​⁠

[@pramodbhamat9610]

Thanks for sharing

[@shawezmalik6823]

Nice information sir

[@shawezmalik6823]

Dear sir one training give all of us
Contaminated control strategy in Aseptic Area

[@sandipjadhav9402]

Sir,what are the COTS,
It requires RA and Impact assessment in COTS

[@PHARMAVEN]

COTS is Commercial Off The Shelf meaning an equipment which is readymade and we are buying it as per specifications provided by manufacturer
We may have to perform Risk Assessment based on how critical the equipment is.
For example, incubator or stability chamber we may take as provided by Thermo Scientific then it is COTS but we may need a formal RA because of it’s critical use of incubation of EM Plates

[@sandipjadhav9402]

Thank you very much sir

[@Pharma-Grow]

Which solution used for Smoke study ?

[@PHARMAVEN]

Different types
Glycerol Based
Water Based
Dry Ice

[@Pharma-Grow]

Ok sir thank you