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One of the most intelligent moves I’ve seen a corporate Stability organization make was the establishment of a Stability Intelligence (SI) Specialist within its ranks. Someone whose primary responsibility was to continuously monitor the [...]
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After decades of watching the ICH Stability-related Guidances grow and even stagnate, a major initiative to consolidate, expand, clarify and become more relevant to the users has just come through an industry-wide review and [...]
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The presence of traces of N-Nitrosamine impurities in pharmaceutical products was first noted around 2018 in some sartans, particularly sartans that contained a tetrazole ring in their chemical structure and specifically Valsartan. It soon became [...]
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Disasters occur whether we plan for them or not, but planning ahead to mitigate their impact and recover from their damage can make a big difference in corporate success. While we can’t control the nature [...]
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So, you’ve gone through the process of formulating user requirements, chamber selection and purchase. With the equipment in place; how do we go from this point to GMP operation? Are we required to perform validation [...]
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It’s Stability Information Month and time to go a little further than regulations and processes and talk about people, namely the ones who comprise the Stability Group. Past articles have addressed optimal backgrounds and pathways [...]
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When choosing a stability chamber, it’s essential to consider a range of factors that align with specific needs and conditions. Making the right decision requires assessing conditions like tolerances, space, utilities, monitoring and maintenance [...]
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50 Years Before the Chamber (with apologies to Richard Henry Dana Jr.) At one point in my career, just as I was coming into my own in the Stability community, our departmental director was [...]
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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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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!
