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Mon, 21 May 2018 08:16:26 +0000
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Hi Sally,



Yes you can defend reduced micro testing if your product has a low water content (e.g. <0.6 Aw). Besides water activity you must also consider other product characteristics such as type of product, route of administration, does it support microbial growth / proliferation, what is the natural bioburden of the product or ingredients, bioburden specification etc. Based on the outcome in combination with historical data you might be able to justify to reduce micro testing. Regulators would accept if it is scientifically sound.



Kind regards,

Patrick



The opinions provided are my own and do not necessarily reflect practices or opinion of the company I work for



-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Meredith, Sally
Sent: 20 May 2018 10:19
To: [log in to unmask]
Subject: [PMFLIST] Water Activity for Reduced Micro



Dear PMF members



Has anyone successfully justified reduced micro testing by supplementing water activity instead of USP<61>/<62> using the guidelines in USP<1112> Application of Water Activity Determination for Nonsterile Pharmaceutical Products?



How would auditors and regulators respond to this type of reduced testing?



Thank you for your feedback!



Sally Meredith

Scientist III, Quality Control

Pharma Services

Patheon, part of Thermo Fisher Scientific









This e-mail (including any attachment) is for the sole use of the intended recipient(s) and may contain confidential and/or privileged information. If you are not an intended recipient, please notify the sender immediately and delete or destroy the original and any copy. Any views or opinions expressed in this email are those of the author only.



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