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RE: Question for the Forum
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Dear Alan The USP mentions the wide range of temp. for general storage conditions covering / including the excursions, which is between 15 - 35 deg C. Logically considering that 35 deg C is max. the min is kept at 15, where by 25 becomes the mean / avg., if u look at that way. Applying the same logic, couldn't it be ideal to have the min. / low being 5 deg C, I mean a range of 5 - 25, with 15 being the mean / avg.? Of course this is only my interpretation & would like other forum members to enlighten on this logic pls. regards Madhu From: gmp@www2.pharmweb.net [gmp@www2.pharmweb.net] On Behalf Of Alan Longworth [alanlongworth@norpharm.ie] Sent: Friday, January 11, 2008 3:32 PM To: GMP Forum Subject: Question for the Forum Dear Forum I am setting up temperature monitoring devise in a warehouse for solid dosage product. None of the goods in the warehouse require refrigeration and most of the goods have storage conditions of ?Not more than 25 deg C?. My concern is not about detecting higher temperatures than 25 deg C but more about temperatures of less than 15 deg C being recorded in the warehouse which is unheated. I understood that for goods labelled for storage ?Not more than 25 deg C? there is no recognised lower temperature level of storage but a recent Irish Medicines Board guidance document (based on a similar guide from the MHRA) states that storage conditions of ?Not more than 25 deg C? imply a lower limit of temperature of 15 deg C. I wonder if the Forum have any views on this issue of storage conditions at lower temperatures for solid dosage forms? Alan Longworth Qualified person |
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