Can we write retest date in place of expiry date ? If we write what the evidence for that
Expiry date and retest date are different things. The expired material can not be retested for its use.
Sir i am doing job in API
as par some company requirement can i change expire date to retest date ?
Sir can i take change control to change it ?
if i change it what is the evidence to attach in change control ?
Excipients may be retested but API can’t be used after its expiry.
In API you can mention retest date after 1 year of manufacturing but it should be within the expiry date.
Retest date is cross checking before the expiry date.
kept supporting Hold time / stability studies to change control.
Some manufacturers specify Retest date not expiry date on API containers. e.g. they specify Retest date 2 years after the manufacturing date (Mfg date Oct 2019 and Retest date Sept 2021). Now when we receive this material, suppose already 1 or 2 months already gone in transit and our FP shelf life is 2 years. In this case, if we use this API can we specify 2 year expiry on our product with Mfg date Dec 2019 & Expiry date Nov 2021.
kindly share guideline attachment
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