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Regulating decentralised manufacturing in the UK – a legal perspective

European Pharmaceutical Review

In the EU, the EU pharmaceutical package of reform 5 includes a proposed new Directive, 6 which will replace the current Medicines Directive (2001/83/EC). Technology For the technical operation of a web of sites, systems must enable them to all share data and communicate with each other. Internet] UK Government.

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A New Regulatory Approach to Drive Sustainable Medicines

ISPE

As such there’s a growing question of how the industry will improve the sustainability profile of its existing medicines and ensure that sustainability is designed into new medicines, such as products, with a reduced environmental risk, greener manufacturing technologies, and recyclable delivery systems and packaging. 9 December 2021.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Currently, it takes time and/or communications (e.g., 2005N–0262) Federal Register (2005).

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. Currently, it takes time and/or communications (e.g., 2005N–0262) Federal Register (2005).

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CMC Requirements for New Drug Registration in Latin America

ISPE

In addition to the COR, some Latin American markets require approval in the COO, which is defined as the country where the drug is manufactured, packaged, or exported from. Sometimes, COAs for the drug substance, the excipients used in the formulation, and the primary and nonfunctional secondary packaging material are requested.

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Can holograms help in the frontline fight against pharmaceutical counterfeiting?

European Pharmaceutical Review

One area in which the problem can be tackled effectively is product packaging. With predictions that the global market for anticounterfeiting packaging is set to reach almost $250 billion by 2026, growth in authentication and anti-tamper devices such as holograms appear to have a healthy future.”

Packaging 111
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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Finally, the DP is packaged in a suitable container to ensure continued quality. Published November 2005. You may unsubscribe from these ISPE communications at any time.