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Standards & Regulation

Business & Regulation Standards & Regulation

The Fight for Transparency

| James Strachan

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

Business & Regulation Packaging

Serialization Standardization

| Stephanie Vine

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

Business & Regulation Biosimilars

Negotiating GDUFA II

| James Strachan

Are reduced GDUFA fees on the horizon for contract manufacturers?

Manufacture Biosimilars

The optimization and scale-up of high shear granulation

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.

Business & Regulation Formulation

All Aboard for Continuous Coating

| Jason Teckoe and Charlie Cunningham

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

Manufacture Standards & Regulation

Regulating a 3D-Printed Future

| Akm Khairuzzaman

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

Business & Regulation Biosimilars

Walking the Biosimilar Guideline

| James Strachan

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

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.

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.

Business & Regulation Facilities

Room For Improvement

| Brian G Hubka, Jeanne Moldenhauer

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

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