February 2020


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Stan Alekman <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Wed, 26 Feb 2020 22:24:37 +0000
text/plain (49 lines)
Check out the following quoted passage from the June

1998 Draft Stability Guidance of Drug

Substances/Products, page 44: [Link =>]


"The computation of the expiration dating period of

the drug product should begin no later than the time

of quality control release of that batch, and the date

of release should generally not exceed 30 days from

the production date, regardless of the packaging date.

The data generated in support of the assigned

expiration dating period should be from long-term

studies under the storage conditions recommended in

the labeling. If the expiration date includes only a

month and year, the product should meet specifications

through the last day of the month."

Stan Alekman

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