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Quality & Compliance

Manufacture Facilities

Nominations for The Power List 2017

| Stephanie Sutton

Nominations for the 2017 Power List are now open and will close on February 1, 2017.

Business & Regulation Quality & Compliance

Tackling Challenges and Change Together

| Susanne Keitel

The latest edition of the European Pharmacopoeia was published in July 2016 and some large changes are afoot.

Business & Regulation Quality & Compliance

Building a QbD Masterpiece with Six Sigma

| Jasmine

Many people struggle with QbD, but there are secrets to success…

Manufacture Business Practice

Raising Standards

| Susanne Keitel

Sitting Down With… Susanne Keitel, Director of the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe in Strasbourg, France.

Manufacture Technology and Equipment

Still Sieving...

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Isn’t it time to move with the times and relegate manual and outdated processes?

Manufacture Quality & Compliance

Turning Failure into Success

| Stephanie Sutton

We should look to Warning Letters – and the subsequent solutions – to benefit from the blunders of others.

Business & Regulation Packaging

Insights into Elemental Impurities

| Dennis Jenke

Packaging components can leach into drug products and become foreign impurities. Guidelines exist for the testing of drug products for elemental impurities, but how are these applied to elemental impurities derived from drug product packaging?

Manufacture Quality & Compliance

Thinking Outside the Tox

| Sandy Mackay

Decisions around toxicology testing must be made using scientific methods, not emotions or politics.

Manufacture Small Molecules

Codes, Drugs, and Rock ‘n’ Roll

| Mark Davison

Europe has set the stage for safer supply chains with its Falsified Medicines Directive. Next, the spotlight could fall on using serialization to boost patient centricity.

Discovery & Development Business Practice

Relative viscosity screening of monoclonal antibody formulations at low concentration and viscosity

Viscosizer TD provides automated relative viscosity measurements with high reproducibility at low viscosity, to help identify molecules with abnormally high viscosity-concentration profiles at low sample concentrations as early as possible in the development pipeline

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