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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). 3 (2022):593–607. October 2022. Blood 140, supplement 1 (2022):10323–24.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3 Published 15 November 2021.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3 Published 15 November 2021.

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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

Mon, 08/29/2022 - 15:46. September / October 2022. 1 September 2022. 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. Trudy Patterson.

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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

Mon, 08/29/2022 - 20:53. September / October 2022. 1 September 2022. In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Finally, the DP is packaged in a suitable container to ensure continued quality. Jacqueline E.

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Environmental Sustainability in Biopharmaceutical Facility Design

ISPE

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). Accessed 3 December 2022. 7 November 2022. Accessed 3 December 2022.

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An Evaluation of Postapproval CMC Change Timelines

ISPE

In addition to delaying optimization of manufacturing and controls, these types of long delays for approvals discourage continuous process improvements for approved products. 1 (January/February 2022). Bolivia, Hong Kong, Malaysia, Philippines, and Vietnam). Cauchon, T. Hedberg, M. Braathen Holm, J. Lepore, et al.