Pharmaceutical Technology, September 2022

The Value of Primary Working Standards in Pharmaceutical Quality Control

September 03, 2022

Peer-Reviewed Research

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It is argued that orthogonal quantitative methods can be used to establish primary working standards. An example details how to calculate the expanded measurement uncertainty (U) for the certified assay value by considering two orthogonal assay methods.

How Integrated Project Delivery Enables Speed: A Phase-By-Phase Guide

September 02, 2022

Operations

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9

By eliminating the waste involved in traditional approaches to project set-up and execution, integrated project delivery helps innovators in the European life sciences market meet their fast-track delivery targets.

Industry 1VQ Solutions: Change of Lot or Extension of Shelf-life of Reference Standard

September 02, 2022

Quality

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9

Change of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.

Vaccine Disconnect

September 02, 2022

From The Editor

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9

More than anything else MonkeyPox and COVID-19 have shown that we are interdependent, no matter what continent you call home.

What Impact Will the New Unitary Patent System Have in Europe

September 02, 2022

Regulatory Watch

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A new unitary patent system is due to come into effect in Europe later on this year.

Winter is Coming!

September 02, 2022

From The Editor

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9

As winter approaches, the next generation of COVID-19 vaccines are being prepared and scheduled, ready for distribution across Europe and the world.

What Does Cost Mean?

September 02, 2022

From the CEO

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While the cost of certain medicines are alarmingly high, they can be considered a bargain measured against a lifetime of traditional costs.