Standards & Regulation

The EMA says “yes” to transparency, but some pharma companies have other ideas.

A consortium of vendors and pharma companies search for a single, serialization standard.

Are reduced GDUFA fees on the horizon for contract manufacturers?

This article explains how an inline probe was used to monitor a granulation at three different scales to confirm that, in each case, the granules produced were the same size, and more importantly produced tablets of identical quality as quantified by hardness.

Robust formulation and coating expertise are required to get the best results with continuous coating.

Sitting Down With… Akm Khairuzzaman, a 3D printing expert from the FDA.

Not all successful biosimilar applications in Europe follow guidelines to the letter

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

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.

Today’s cleanrooms may meet current quality standards, but what about the future?