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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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Introduction Stability programs are an essential part of life but represent a huge investment for any pharmaceutical company. We are completely dependent on our stability chambers to keep running year after year but in [...]
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Many pharmaceutical companies make use of Contract Development and Manufacturing Organizations (CDMOs) to help them develop new products. Within the CDMO, Formulation Development and Analytical Development Scientists work together as teams to help client companies [...]
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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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Whether you planned a career as a Stabilitarian or landed on the Stability Group, intending it to be the next toehold on the rock wall to success, you have options to build career capital. Work [...]
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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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My Stability career started at the bottom, a lowly Assistant Formulator who submitted our latest attempts in constructing a palatable medicinal liquid that would stand up to 40C for 6 months; products had it tougher [...]
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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!
