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). 7 December 2017. 1 December 2017. 7 An integrative (vs. 7 An integrative (vs.

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Packaging Labelling Health Compliance Process Improvement 52

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. BioProcess International 15 (September 2017):24–47.

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Documentation FDA Communication Packaging 52

ISPE

SEPTEMBER 10, 2023

In addition to delaying optimization of manufacturing and controls, these types of long delays for approvals discourage continuous process improvements for approved products. PDA PAC iAM 2017 Survey on Post Approval Change: Is the Regulatory Environment Hindering Much-Needed Innovation in the Pharma Industry?” 5 (2017):421–27.

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Documentation Process Improvement Packaging Pharmaceutical Companies 98