ISPE

JULY 5, 2023

This article discusses how US regulators addressed the regulatory hurdles related to CM to broaden its adoption through engagement, regulatory science, guidance, and international harmonization. Generally, CM is fit for processes with high repeatability requirements, as is the case for pharmaceuticals.

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FDA Dosage Documentation Pharmaceutical Companies 52

ISPE

SEPTEMBER 11, 2023

Considerations for a Decentralized Manufacturing Paradigm Trudy Patterson Mon, 09/11/2023 - 06:47 Features September / October 2023 Considerations for a Decentralized Manufacturing Paradigm Marquerita Algorri, PhD Ting Wang, PhD Jocelyn X. McQueen Nina S.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

JULY 7, 2023

USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics Trudy Patterson Fri, 07/07/2023 - 08:45 Features July / August 2023 USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics John F. This article summarizes trends from the workshop and ponders next steps. 1 a b c Gerstweiler, L.,

FDA 52

FDA Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MARCH 6, 2023

Challenges for Net Zero Carbon Pharmaceutical Manufacturing Trudy Patterson Mon, 03/06/2023 - 12:40 Features March / April 2023 Challenges for Net Zero Carbon Pharmaceutical Manufacturing Keith M. Finalized 9 August 2021. 1 Intergovernmental Panel on Climate Change (IPCC). C global warming scenario.

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Packaging Pharmaceutical Companies Pharmaceutical Companies Compounding 52