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Module Type Package: Turning Visionary Concepts into Reality

ISPE

Module Type Package: Turning Visionary Concepts into Reality. Module Type Package: Turning Visionary Concepts into Reality. The Module Type Package (MTP) approach designates each module with a digital description, enabling flexible module connection and orchestration. Download White Paper. Trudy Patterson.

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The Digital Validation Handbook Your Guide to Faster, More Accurate Validation

ISPE

From cave paintings to emails, we now communicate faster, clearer, and from greater distances. Download White Paper To download this white paper, complete the form below. Once submitted, you will receive a link via the email you provided to download the white paper.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. Currently, it takes time and/or communications (e.g.,

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. Currently, it takes time and/or communications (e.g.,

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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). Nature Communications 12, no. Biotechnology Progress 36, no. 3 (2020):e2970.

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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. You may unsubscribe from these ISPE communications at any time.

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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.