Remove 2023 Remove Pharmaceutical manufacturing Remove Pharmaceutical products
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Navigating the regulatory challenge of PFAS for pharmaceutical manufacturers

European Pharmaceutical Review

This poses a significant challenge for pharmaceutical manufacturers, not least because of the technical challenges related to operations, supply chain and the environment. This article explores the potential impact of the proposal and considers how manufacturers can ensure the safety and reliability of their products.

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Transforming pharmaceutical manufacturing: The AI revolution

European Pharmaceutical Review

Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift. Figure 1 : adapted from Saha, G. Tuijin Jishu/Journal of Propulsion Technology, 44(3), 1384-1392.

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EU Urban Wastewater Treatment Directive may compromise EU medicine availability

European Pharmaceutical Review

Based on the new cost estimates, pharmaceutical manufacturers in Finland alone will be required to fund 280816 million of these expenses, The directive , enforced on 1 January 2025, imposes an extended manufacturer responsibility on the removal of micro-pollutants from wastewaters.

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PDA revises report on glass container manufacturing

European Pharmaceutical Review

Revised for 2023, the Parenteral Drug Association (PDA) has published an update to its Technical Report No. 43: Identification and Classification of Nonconformities in Moulded and Tubular Glass Containers for Pharmaceutical Manufacturing.

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Getting ahead of regulatory changes around PFAS in pharmaceutical packaging

Clarivate

Nitrosamines have garnered significant attention from the pharmaceutical industry due to their detection in commonly prescribed medications for conditions like type 2 diabetes, high blood pressure, and heartburn. [1] 5] Research is beginning to link PFAS to an increase in kidney cancer rates, reproductive challenges, and thyroid issues. [5]

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Strengthening and transforming the pharmaceutical supply chain

European Pharmaceutical Review

Europe, too, has faced similar issues with its pharmaceutical supply chain, including critical shortages of antibiotics such as amoxicillin. Recent guidance published by the European Medicines Agency outlines measures that will be taken to increase preparedness for the autumn/winter 2023-2024. How can these issues be addressed?

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WHO cough mixture health alerts raises questions about slack compliance in manufacturing

Pharmaceutical Technology

In this instance of contaminated cough syrups, the concern is around an excipient in the product and not the active pharmaceutical ingredient (API). It is therefore essential that all components used in the pharmaceutical manufacturing process and not just the API must be assessed and tested to full monograph specifications.