As an API supplier, if you set a retest period instead of a shelf life,
the COA has a retest date:

 

1.	Do you have to test the material ON that date, or just prior to
use, past that date?
2.	If you retest 'prior to use' what is the time frame for using
the material?  14 days, 30 days, ...?
3.	Is it the responsibility of the purchaser to retest their
material at/after the retest date.  Or does the API supplier have to
test it and send out new COAs to all the purchasers?
4.	If you set a retest date, once you reach that date, do you
retest prior to each use.  Or do you set a new retest date based on the
retest period?
5.	If you set a retest date, do you also set an expiry date?
6.	If the material is a sterile product, does this change any of
the above?  Since you need to verify continued sterility at the end of
shelf life (or retest period).  

 

 

ICH Q1A explains the differences in the definitions, but doesn't address
practical implications/logistics of being a supplier to outside
customers.

 

 

Sharon Blaha

Stability Manager

 


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