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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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Tackling fake pharmaceuticals: an industry united against counterfeit products

European Pharmaceutical Review

Consequently, pharmaceutical manufacturers risk their reputation if impersonating products fail to deliver the expected quality or health impact. These may be mislabelled or produced in fake packaging and, most dangerously, there is no regulation around their manufacture. But what exactly does this look like? .

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Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing

European Pharmaceutical Review

Implementing PAT in (bio)pharmaceutical manufacturing New sensors or larger equipment with more complex setups (software and hardware) require stringent procedures to become fully implemented in a good manufacturing practice (GMP) manufacturing facility.

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Deviation investigation guidelines in the pharmaceutical industry

GMPSOP

In the five years between 2019 and 2023, the FDA issued the following warning letters, closely related to ineffective deviation investigation. Adulterated Pharmaceuticals: 396 warnings iii. Packaging/labeling/Misbranding: 41 warnings vi. Many of those are direct results of ineffective or no-deviation investigations.

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Building CO2-neutral, defossilised supply chains for chemicals

European Pharmaceutical Review

2 However, most of these efforts relating to catalysis, 3 process waste metrics, 4 lifecycle assessments, 5 pharmaceuticals in the environment 6 and the phase out of substances of concern 7 mainly mitigate the consequences of pharmaceutical manufacturing. Defossilization of pharmaceutical manufacturing.

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FDA warning letters highlight CAPA concerns

European Pharmaceutical Review

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. Eight FDA warning letters were handed to European companies in 2018.

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Is J&J nearing the end of its opioid liability hangover?

pharmaphorum

According to the AP, around 40 states have now signed up to the national settlement package, which could be announced later today. From 1999–2019, nearly 500,000 people died from an overdose involving any opioid, including prescription and illicit opioids, according to figures from the US Centre for Disease Control and Prevention (CDC).