Quality & Compliance

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

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

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.

Isn’t it time to move with the times and relegate manual and outdated processes?

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

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?

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

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.

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

... or sonicate until the cockroaches disappear. When writing is central to the job of assuring health, safety, and quality, can you afford to be loose with language prone to misunderstanding? Why take a chance? Here are a few strategies to edit your written work for quality control.