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In the pharmaceutical, food, and chemical industries, product stability is paramount. Ensuring that a product maintains its quality, potency, and safety over its intended shelf life is critical for both consumer safety and business [...]
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Stability studies are critical for ensuring the safety and efficacy of pharmaceutical products over time. However, managing the risks associated with these studies presents a considerable challenge. These risks can stem from numerous factors, including [...]
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Cosmetics are different, yet similar to pharmaceutical formulations in that they’re susceptible to temperature, humidity, light, and microbial contamination. An unstable cosmetic can no longer fulfill its mission in creating a better appearance. As in [...]
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For decades, Quality Subject Matter Experts have been stating that it is critical for all aspects of the Medical Product industry to get off paper and digitize as soon as possible. This genesis of documentation [...]
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Data Integrity (DI) has been an issue in Japan as it has been internationally, and many companies have established SOPs specific to DI. DI is very briefly described in three guidances in Japan, which are:Article [...]
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May was Stability Information Month, and the information sources did not disappoint. This month’s (June 2024) Newsletter carries the hot topics that emerged from StabilityHub’s Office Hours, the PSDG Meeting at KENX’s Laboratory University [...]
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In a search for medical product stability information, Google or Bing have probably been the first place most of us have gone. StabilityHub was created with the aim to become the top choice in finding [...]
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What did the pharmaceutical world do for photostability before ICH Q1B came along in 1996? Undoubtedly, to mimic real world light exposure situations our scientists used dependable scientific method and justified their protocols sensibly. Research [...]
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The Stability Manager stood in the 25C/60%RH chamber with his QA Director on one side and the FDA Inspector on the other. The Inspector pointed to a bin on an upper shelf and asked, “Can [...]
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What is really going on with a desiccant pack over the life of your study? It turns out these little guys are giving it all they’ve got to keep our product from failing moisture specifications. [...]
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A stabilitarian encounters new situations every day. StabilityHub’s discussion forums give Stabilitarians an opportunity to ask questions and offer solutions to specific scenarios. Join in the conversations with other Stabilitiarians and share your knowledge!
