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Considerations for a Decentralized Manufacturing Paradigm

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4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). Pharmaceutical Processing World. 1 May 2015. Nature Communications 12, no.

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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

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Following approval of an initial marketing application, postapproval changes are needed to ensure adequate supply, mitigate supply risk, expand patient market access, optimize manufacturing processes, improve analytical methods, and comply with new regulatory expectations. Common Technical Document [CTD] sections). 26 Tschorn, U.

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Environmental Sustainability in Biopharmaceutical Facility Design

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Sustainability Tools and Design Processes When promoting of an initiative’s environmental sustainability ES, we should include a more comprehensive context that considers planet (natural capital), people (social capital), and profit (economic capital). October 2015. However, it can also reduce the environmental burden of a process.