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USP General Chapter —Glass revised

European Pharmaceutical Review

In response to supply chain challenges, including shortages of critical glass vials for products like COVID-19 vaccines and parenteral drugs, the Packaging and Distribution Expert Committee (PD EC) has made a significant revision of United States Pharmacopeia (USP) General Chapter <660>—Glass.

Packaging 105
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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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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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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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FDA Issues Long-Awaited QMSR Final Rule

The FDA Law Blog

Both ISO 13485 and ISO 9000 contain terms and definitions that are referenced within Part 820. FDA further retained some definitions in the QSMR. FDA further retained some definitions in the QSMR. Certain definitions are also removed from § 820.3, Revised § 820.3

FDA 59
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European PFAS restriction could jeopardise pharmaceutical manufacturing

European Pharmaceutical Review

EFPIA highlighted that the legislation would apply to packaging materials using fluoropolymers, or combination products such as pre-filled syringes. However, not all PFAS have the same hazardous properties with some considered of low concern by the Organisation for Economic Co-operation and Development (OECD), EFPIA noted.

Packaging 105
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How to Have a Holly Jolly Hempmas

DiversifyRx

With the upcoming holidays, let’s talk about how you can leverage Ananda Professional’s packages they just launched to help boost patient satisfaction and pharmacy profits! Maybe having just a couple of single packages up by the register and a bigger display where people are sitting. Use Customer Incentives.