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European PFAS restriction could jeopardise pharmaceutical manufacturing

European Pharmaceutical Review

According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), more than 600 essential medicines are at risk if a proposed restriction on the use of fluorinated substances, per- and polyfluoroalkyl substances (PFAS) across pharmaceutical manufacturing in the EEA, is implemented.

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Elevating pharmaceutical manufacturing processes with real-time insights

European Pharmaceutical Review

These insights help to drive highly efficient manufacturing processes, ensuring competitive product delivery on time and within budget. However, historically, NMR instruments have rarely been deployed during the later stages of pilot testing and manufacturing operations, even when driven by PAT setups.

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Unified vision essential in UK advanced manufacturing

European Pharmaceutical Review

The Association of the British Pharmaceutical Industry (ABPI) has drawn attention to a new report , which has emphasised the importance of UK advanced manufacturing requiring a long-term strategy to ensure its continued success. Article: Are we globally prepared for the next pandemic?

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Joint investment to accelerate UK sustainable biomanufacturing

European Pharmaceutical Review

UKRI highlighted that overall, these investments will “enhance the UK’s global competitiveness by supporting research and innovation that leads to new and disruptive biomanufacturing processes across the UK.” Curious about sustainability in pharmaceutical manufacturing and the supply chain?

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Is the pharmaceutical sector realising its potential for sustainable manufacturing?

European Pharmaceutical Review

Globally, the pharmaceutical sector emitted around 52 megatonnes of CO 2 in 2015, the most recent period for which detailed numbers are available. 1 Every major pharmaceutical manufacturer in the UK and Ireland is investing in making their operations and supply chains more environmentally friendly.

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Economics and risks of FDA’s Quality management maturity rating programme

European Pharmaceutical Review

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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Embracing automation in sterile manufacturing

European Pharmaceutical Review

Historically, pharmaceutical manufacturers have built sufficient capacity so that they can leverage sudden surges in demand. Some of the primary packaging material has enormous lead times so we’re having to stock up on inventory” The second issue is with primary packaging material.