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). 12 April 2016. Pharmaceutical Processing World. October 2022. Madhyastha.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

OCTOBER 27, 2022

Since 2016, drug approvals per clinical campaign have outpaced the average across all modalities, resulting in 11 FDA-approved therapies in that span. 5’-(E)-Vinylphosphonate: A Stable Phosphate Mimic Can Improve the RNAi Activity of siRNA-GalNAc Conjugates.” 11 (2 June 2016): 985–89. Brigham, et al. “5’-(E)-Vinylphosphonate:

Process Improvement 98

Process Improvement Packaging Dosage Compounding 98

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). However, it can also reduce the environmental burden of a process.

Packaging 52

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 14 (2016): 38–43. Smith, and R.

Documentation 52

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. On this basis, country approvals covering 2016–2020 were included in the analysis. Bolivia, Hong Kong, Malaysia, Philippines, and Vietnam).

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Documentation Process Improvement Packaging Pharmaceutical Companies 98