PharmExec

NOVEMBER 8, 2022

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

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ISPE

SEPTEMBER 11, 2023

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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ISPE

AUGUST 29, 2022

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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ISPE

MAY 9, 2023

In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceutical companies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements.

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ISPE

JANUARY 10, 2023

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. Published November 2019. pdf 6 a b c US Food and Drug Administration. 3 Ramanadham, M.

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