BioPharm International-09-01-2014

This article is the third and final in a series designed to offer leaders and managers at all levels in the industry a road map to excellence in human performance and human error prevention.

Global News

September 01, 2014

Chinese healthcare reforms may be a double-edged sword for foreign companies.

As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.

Perspectives on Outsourcing

September 01, 2014

Annual study shows geographic proximity not a factor in CMO selection.

Regulatory Beat

September 01, 2014

FDA demands accurate manufacturing and test information to ensure product quality.

Careful selection of downstream processing conditions is a must.

Vial adapters can reduce variation of volume withdrawn from injectable drug vials.

Compliance Notes

September 01, 2014

A well-constructed quality agreement can be an important tool to enable effective collaboration between owner and CMO.

Guest Editorial

September 01, 2014

Industry associations play a strong role in helping the pharmaceutical industry meet challenges.

Developing and maintaining a current master plan for cleaning in multi-product facilities are crucial.

Features

September 01, 2014

Program review can help quality risk management live up to the promise of ICH Q9.

Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers face in facility design

Analytical Best Practices

September 01, 2014

Design space generation is encouraged in new product development.

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