I would like to know about the temperature and RH excursions as how much temperature and RH excursions are allowed in GMP area? USP states the tolerance uptown 24 hours but that is applicable only to warehouse storage.
Response will be highly appreciated.
This a very generic question. It all depends upon type of products and manufacturing activities performed in GMP area. Generally, temperature excursions up to + - 2 deg C and relative humidity excursions up to + - 5% of the set values are acceptable.
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yes ,i am agree with Mr. Sunil Budhkar…
Thank you very much Mr. Sunil for your response. However I would like to know if any references are there.
Thank you.
There’s commonly teprature limit NMT 25°c for control Area And RH NMT60%.
However limits vary from product to product whether it’s temperature sensitive or humidity sensitive
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