Packing Validation & Accelerated Aging Test

M

mpfizer

Involved In Discussions
#1
#1
Hi,

Is accelerated aging test considered to be a part of packing validation or if we are supposed to do packing validation has accelerated aging test also to be performed ?
Which are the other tests mandated to be performed for packing validation.

Thanks

Michelle
 
GAGEpack - Gage & Calibration Management
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M

mpfizer

Involved In Discussions
#2
#2
sorry ..but i had asked a similar question earlier ...the labs here have opposite views, one lab says that in packing validation as per ISO 11607 accelerated aging must be included and the other says not required ... hence the need for clarification...

Thanks
michelle
 
planB

planB

Super Moderator
#3
#3
Have a look into ISO 11607-1:2019, sections 8.2.2 and 8.2.3:

8.3.2 Stability testing shall be performed using real-time aging.
8.3.3 Stability testing, using accelerated aging protocols, shall be regarded as sufficient evidence for claimed expiry dates until data from real-time aging studies are available.
Click to expand...
Hope this helps,
 
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