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Ben Was Right QC and analytical labs are facing heightened expectations as method lifecycle principles, data integrity, and digital lab tools reshape the regulatory landscape. This article (with a good deal of help from [...]
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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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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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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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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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When assembling a Stability Program, right after a QC laboratory and stability chambers, a Statistics plan would be high on our list. Whether we have one now, contract it out or are planning for the [...]
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Is it time to reseed your stability group? It’s autumn and with cooler weather, I was re-seeding some sparse patches in my lawn when the thought occurred; this process has an analogy for Stabilitarians. Are [...]
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This page contains a list of all of our content classes and their subclasses. Chambers All points in the lifecycle of environmentally controlled and monitored spaces, including acquisition, commissioning, validation, maintenance, and excursions. [...]
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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!
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!
