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Status:Closed    Asked:Apr 12, 2013 - 07:04 AM

When do the requirements of 7e superceed 7d in relation to the pharmaceutical industry

My understanding is that 7e is due to replace 7d but I don't know when

 
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7E was never set to "superceed" 7D. ISTA was simply going to remove 7D as a test because there was not sufficient data behind the temperature profiles. At the time 7D was created, ISTA had 5B a guide to development of your own temperature profiles and it include some examples of what profiles developed according to the process might look like. Well the industry simply took those profiles and starting using them without conducting any temperature study on their own according to 5B. So ISTA with the add of people from the parcel shipment carriers pulled together the best shot at profiles to provide the industry with profiles they could use. Another words more thought went into the 7D profiles that we had put into 5B examples. At least we wanted to feel as comfortable as possible with profiles knowing that people were going to use them and not study their own lanes.


7E came about because the pharmaceutical industry needs data and more data to defend cold chain package designs. 7E was a hugh undertaking and it confirmed profiles that pharma companies had also recently developed.


But, ISTA received push back, mostly from Medical Device Manufacturers that had been using 7D successfully not to remove the it. So we changed our minds and left 7D in place.


I would say that the Pharma industry itself will make the determination of 7E superseeds 7D.

 

Apr 12, 2013 - 07:03 AM

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