BioPharm International-06-01-2013

A Q&A with SCHOTT Pharmaceutical Systems and West Pharmaceutical Services

Bills to regulate drug compounding and establish a national track and trace system face political and policy differences.

Outsourcing Insights

June 01, 2013

Approvals of new drugs are on an upward swing, but only a few CMOs are benefiting.

A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes.

An integrated focus on product design, development, operation, and control.

Global Report

June 01, 2013

The Taiwanese government engages in regulatory science in a move to boost its pharmaceutical sector.

From the Editor

June 01, 2013

Ranbaxy's $500 million settlement for producing adulterated drugs and fradulent data provides a cautionary tale for patients, FDA, and drug manufacturers.

Manufacturing Best Practices

June 01, 2013

Maintaining flexibility in biopharmaceutical manufacturing can deliver positive results.

Emerging Markets

June 01, 2013

A unique demographic and payer mix make ASEAN an increasingly attractive region.

Inside Standards

June 01, 2013

Companies can use metrics as a tool to help drive positive change and quality process improvements.

The authors provide common misconceptions and key concepts behind reliability engineering.

Click the title above to open the BioPharm International June 2013 issue in an interactive PDF format.