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Hello Everyone,
I need assistance regarding the determination of shelf life of a pack. Our company perform sterility test (Stasis test) on the outer cover of the expired pack. In that way we could justify that product is still sterile after the expiry and we can give expiry date . Now the problem is, we didn?t use sterility testing validation method for that particular product.
As per TGA requirement , Company need to perform validation of sterility testing of specific product and then perform the sterility testing on that product.
Is there any way, I can justify that the test is still valid even those the test method was not validated and regulator can consider that.
Thanks in advance
I need assistance regarding the determination of shelf life of a pack. Our company perform sterility test (Stasis test) on the outer cover of the expired pack. In that way we could justify that product is still sterile after the expiry and we can give expiry date . Now the problem is, we didn?t use sterility testing validation method for that particular product.
As per TGA requirement , Company need to perform validation of sterility testing of specific product and then perform the sterility testing on that product.
Is there any way, I can justify that the test is still valid even those the test method was not validated and regulator can consider that.
Thanks in advance
