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Shipping Validation

Hi ,
Myself Pankaj ,I want to know about Shipping Validation /Transport validation ;what type of approach should we follow ??

seeking help .

Tx

First, you need to define what your requirements are for shipping / transport (survivability). There are standards, look at:

http://www.astm.org/cgi-bin/SoftCart.exe/DATABASE.CART/REDLINE_PAGES/D4169.htm?E+mystore

If you intend to follow these, there are testing shops that will validate your product against these.

Dear Pankaj,

I may not be wrong, ur Pankaj kr sharma, PBL.

The aim of shipping validation is to ensure the storage conditions in Transportation. B’ cos ur storage conditions are controlled (normally below 25 deg.C) and in most of the cases the drugs are labelled store below 25 / 30 deg.C

The above two conditions are possible. B’ coz the pharmaceutical manufacturer is following the same under GMP, also the depots, retailers and customers can follow the same as per label claim. But the transport conditions are not in a controlled manner. So, the transport conditions are required to validate that the transport conditions are controlled and within the limit. (it is mandatorly required for products which required the storage conditions below 20 deg c)

Normally the Shipping validation is required by regulatory bodies like USFDA, MHRA and ANVISA. So, u have to follow them.

For short term deviations from storage conditions are evaluated by Accelerated Stability Studies.

thanks …well …you are right …myself pankaj kr.sharma PBL.
;).on the part of continuation of shipping validation can you further tell me content’s of protocol and critical parameter’s to be recorded for this activity.

Tx