Use of API in his last month of validity

GOOD MANUFACTURING PRACTICE (cGMP) REGULATORY TRENDS AND QA
1

Hello everybody,
Wish you a happy new year and a lot of good things

Could you please help me with below:
I’m searching a guideline talking about the use of API in his last month of validity; I received a letter from authorities asking for a full test if I use an API in his last month (full test from supplier of API)

Is there anything talking about this??

Thank you in advance

2

please I need a response
I’m reading ICH, and I didn’t find anything till now

Thank you in advance

3

In general there is nothing by the ICH, FDA, EU… However, it may be required by Indian regulators who have their own legislation. They should cite this piece of legislation.

4

I also assume the manufacturer has the required stability data to justify the use of the API in the last month. If there is no data, don’t be surprised if you are asked this question by the regulator!

5

thank you for replying,
the supplier didn’t send me any justification of the use of his API in his last month
I thought that there is something on the references like ICH or FDA…