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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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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. Accumulus Synergy White Paper. Common Technical Document [CTD] sections). doi:10.1016/j.xphs.2021.09.046.

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Quality first: How pharma can meet injectables demand while staying compliant

Pharmaceutical Technology

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.

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CMO Moves: Regulatory catalysts for drug manufacturing – March 2023

Pharmaceutical Technology

Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions. Sharp Packaging Services is producing the solid dose of the drug and packaging it.

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How smart manufacturing is optimising processes and reducing costs in the pharma supply chain

Pharmaceutical Technology

Forward-thinking suppliers, including packaging component providers, are also looking at how they can improve their processes through digital technologies. Tom Lenaerts is head of global process engineering for Datwyler, a leading supplier of parenteral packaging components such as stoppers and plungers. By Datwyler. United Kingdom.

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‘Right shoring’ API production in Europe

Pharmaceutical Technology

The European Commission plans to launch its revised EU pharmaceutical package in Q1 2023 to ease drug shortages,” she says. Among other things, supply chain optimisation, maintaining access to affordable vaccines, and supporting innovation for unmet clinical needs will be the discussion topics, she adds.

Packaging 105
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Optimizing lyophilization cycle times and improving stability for complex injectables 

Pharmaceutical Technology

PM: Lyophilization is widely used in the pharmaceutical and biotech industry for small molecule drug products, vaccines, antibodies, and other biological material. That would not allow sufficient time to manufacture, package and distribute before half of the content was degraded. A great example is aspirin.