PEER-REVIEWED RESEARCH

The Human Microbiome Project and Pharmaceutical Quality Control Microbiology

The Human Microbiome Project has increased our understanding of the relationship between humans and microorganisms. The authors offer a new perspective on how this knowledge should be considered in setting standards for pharmaceutical quality control in microbiology.
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API SYNTHESIS & MANUFACTURING

FDA Steps Up Foreign Inspections

New legislation and changes in policy at FDA are leading to better control of the API supply chain.
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TROUBLESHOOTING

Designing Trouble-Free Freeze-Drying Processes

Efficient freeze-drying processes result in time and energy savings, reduced failure rates, and improved batch consistency.
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OUTSOURCING REVIEW

More Evidence that Size Matters

Big service providers get bigger faster thanks to Big Pharma.
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REGULATORY WATCH

The Role of Regulatory Advice in Drug Development

Drug developers understand the importance of early communication with regulators, but is EMA providing enough flexibility and support to companies?
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EMERGING MARKET REPORT

Drug Discovery and Development in India

Hope abounds for local drug discovery companies despite challenges at home.
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OTHER FEATURES

Evaluating Package Integrity

Industry awaits the final revision of USP General Chapter <1207> and the impact it will have on the evaluation of sterile product package integrity.
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Evaluating the Impact of the Falsified Medicines Directive in Switzerland

As the prevalence of falsified medicines continues to increase, Switzerland is taking measures to secure its supply chain such as the implementation of serialization.
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Highlights at Pharmapack Europe 2015

A review of some of the latest packaging and drug-delivery innovation presented at Pharmapack Europe.
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Webcasts

Practical Guidance for Successful Mammalian Cell Banking & Cell Line Characterization

Thursday, May 14, 2015, 11 am EDT/8 am PDT/16:00 BST/17:00 CEST
Join this informative webinar, presented by the team at Eurofins Lancaster Laboratories, to learn about the various aspects of cell banking and cell line characterization, including GMP production master and working cell banks, GMP non-production (e.g. bioassay) master and working cell banks, R&D cell banks or banking for end of production cells.
Sponsored by: Eurofins Lancaster Laboratories
Register Free

Practical Implications of the Lifecycle Approach to API Process Validation

On Demand
API process validation experts describe the different activities required during the process design and process qualification stages, as well as continued process verification throughout the life of the commercial process. Hear about key requirements for API process validation including regulatory requirements, manufacturing conditions, data collection, testing to be performed, sampling plans, and analytical method validation.
Sponsored by: Regis Technologies Inc.