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2022 spells change for EU pharmaceutical legislation

European Pharmaceutical Review

It is too early to say because we have not seen the whole package of measures yet. COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Pharmaceutical Strategy for Europe. About the author. References. European Commission.

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Pharmacy practice in emergency care: patient safeguarding

Hospital Pharmacy Europe

ED pharmacy services were surveyed for the first time in 2004. ED pharmacists must know who to escalate their concerns to, as poor communication between professionals and organisations hinders patient safeguarding. So, UK ED pharmacy practice was born.

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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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Considerations for a Decentralized Manufacturing Paradigm

ISPE

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). September 2004. Nature Communications 12, no. September 2004.

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Environmental Sustainability in Biopharmaceutical Facility Design

ISPE

4 The biopharmaceutical industry is taking steps to increase its environmental sustainability, 5 which begins with identifying and testing alternatives to existing procurement, materials, logistics, equipment, services, manufacturing processes, packaging, and facility design 6 (see Table 1). March 2004. 7 An integrative (vs.

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Air Speed Qualification: At Working Position or Working Level?

ISPE

October 2004. But it is likely that interpretations in practice refer to footnote 5 from FDA Aseptic Guidance 2004: 7 “A velocity of 0.45 x, a free and open-source computational fluid dynamics (CFD) software package. You may unsubscribe from these ISPE communications at any time. Pharmaceutical Engineering 37, no.

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Sustainability: Corporate Ambition, Governance, & Accelerated Delivery

ISPE

Representatives from R&D, manufacturing and supply, and commercial should all be included at the top-level forum, along with the main functions needed for delivery such as the sustainability group, engineering, procurement, legal, and corporate communications. Communicating keynote successes will help encourage engagement and support.