Hi,
Water activity is a factor in microbial stability but its measurement alone may not be sufficient to justify the complete elimination of microbial content testing for product release and shelf-life stability. For the regulations, the following sources can be helpful:
https://www.europeanpharmaceuticalreview.com/article/29889/the-role-of-water-activity-in-the-microbial-stability-of-non-sterile-pharmaceutical-drug-products/
https://www.pharmaceuticalonline.com/doc/water-activity-measurements-of-oral-solid-dosage-products-0001
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Shahrokh Ghobadloo
M.Sc., Ph.D., M.B.A.
Ottawa, ON
Canada
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Original Message:
Sent: 14-Dec-2023 16:40
From: Anonymous Member
Subject: Microbiological test at shelf life
This message was posted by a user wishing to remain anonymous
Hello,
It is generally expected that if the water activity for oral solid dosage form is less than 0.6, then the risk of microbial is low. Can we use only water activity as a basis to not test drug products at shelf life for microbiological testing? In this case, it is proposed to test at release only. Any experience with this approach for stage 2 and NDA application?
Thank you for your response.