ISPE
SEPTEMBER 11, 2023
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). Processes 9, no. September 2014. 4 (2014):771–83. 3 (2021):457.
ISPE
MARCH 29, 2023
One possible solution raised was a Module 2 that integrates the product development story, links the product attributes to the drug product (DP) and drug substance (DS) manufacturing processes to demonstrate a holistic drug product control strategy, and demonstrates how the control strategy supports the TPP.
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ISPE
MARCH 29, 2023
One possible solution raised was a Module 2 that integrates the product development story, links the product attributes to the drug product (DP) and drug substance (DS) manufacturing processes to demonstrate a holistic drug product control strategy, and demonstrates how the control strategy supports the TPP.
ISPE
MARCH 15, 2023
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). Green Building Council, 2014. 30 July 2014. 7 An integrative (vs.
ISPE
AUGUST 29, 2022
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. Published July 2014. Lo Surdo, J., Cauchon, C.
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