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Considerations for a Decentralized Manufacturing Paradigm

ISPE

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). These new operating models can help enable and accelerate the efforts of Pharma 4.0™

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Sustainability: Corporate Ambition, Governance, & Accelerated Delivery

ISPE

Future market access for medicines will increasingly depend on sustainability prerequisites being satisfied before being able to supply: for example, risk assessments needed for EU product authorization, 8 and performance data accompanying commercial tenders for UK National Health Service.