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PDA revises report on glass container manufacturing

European Pharmaceutical Review

The long-awaited PDA TR 43 report provides an approach to a quality decision-making process and represents best practices for the identification and classification of visual nonconformities for (empty) glass containers as pharmaceutical product packaging.

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Parallel import of medicinal products: regulatory update

European Pharmaceutical Review

This concerns the quantity of the medicinal product in the packaging, ie, the increase or decrease in the number of units of the product in the outer packaging according to local demands and its labelling, including the leaflet, which should be in the language of the country into which the product is imported.

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Embracing green innovation in life sciences

European Pharmaceutical Review

If we want to lead the way in green innovation and show that the UK is open for business, we need a broader definition and recognition of innovation. Sustainable pharma packaging: breaking down the barriers to adoption Over two years it resulted in approximately 52,000 inhalers being returned, equating to approximately 305 tonnes of CO 2.

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Building CO2-neutral, defossilised supply chains for chemicals

European Pharmaceutical Review

All traditional small molecule pharmaceuticals include carbon building blocks – by definition, organic materials – which are then transformed via modern synthetic chemistry to assemble the complex and highly variable skeletons that the final target structures demand. However, it is already clear that the investments will be gargantuan.

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Sanofi to sell Japanese manufacturing plant

European Pharmaceutical Review

Sanofi has signed definitive agreements with Adragos Pharmaceutical, a German contract development and manufacturing organisation (CDMO), for the sale of its pharmaceutical manufacturing site in Kawagoe, Japan. The French pharmaceutical company will also enter into a long-term supply agreement with the CDMO.

Packaging 104
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Innovation across the healthcare system is needed to realise the value of medicines

pharmaphorum

The answer to this question comes back to our definition of value. If we are to move towards a value-based healthcare system, then we must utilise the power of both clinical trials data and real-world evidence, to produce the best possible data package for regulatory submissions. About the author.

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2022 ISPE Annual Meeting: Transform, Collaborate, & Innovate for the Path Forward

ISPE

Applying what has been learned over the last three years to update pharmaceutical companies’ approaches to development and implementation is key as the industry crafts its strategies in an increasingly digital and global environment. President, U.S. Business Unit and U.S. Country Head.