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Pharmaceutical Executive, August 2022 Issue (PDF)

PharmExec

Click the title above for a link to open the Pharmaceutical Executive August 2022 issue in an interactive PDF format.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

Herein, DM refers to a manufacturing model in which many units or facilities are disseminated across different geographical areas 6 , 7 DM facilities may produce similar or identical products under a unified pharmaceutical quality system (PQS) or operate as independent units with different outputs. Industry 4.0

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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

ISPE

Mon, 08/29/2022 - 15:46. September / October 2022. 1 September 2022. Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. The European Medicines Agency (EMA) issued its implementation guidance in March 2020. Trudy Patterson.

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Rapid Filter or Resin Change Strategies for Biomanufacturing

ISPE

Section 101 of the Defense Production Act of 1950 was extended by Executive Order 13911 in 2020 to Respond to the Spread of COVID-19. Presented at Well Characterized Biotechnology Pharmaceutical (WCBP) Conference. Recorded 25 August 2021. Published August 2020. pdf 6 a b c US Food and Drug Administration.