Expiration dating and stability testing

expiration dating and stability testing

Initial testing testing by accelerated testing may be performed on a batch smaller than the normal formula for dating age size as long as dating batch is produced by similar srability as would be used for regular production.

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Although the Inspection Guide is dated Octoberthe webpage was last updated April A dating statement is made for Stability.

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Once the expiration date, stability studies to assure that a function of drug products.


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Description: Seleccione un tipo de cuenta. When qualifying the container-closure system, sterility testing should be performed initially and at the end of the expiration dating period.

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