Drug Development

Articles

WFI system deficiencies and damp tax records cause problems for two plants

Troubled Waters

The assembly of the World Health Organisation (WHO) later this month is expected to feature counterfeit medicines as one of its important discussion points, and there is some hope that the ministers will agree on measures that will strengthen anticounterfeiting legislation and enforcement worldwide.

The counterfeit problem

When Pharmaceutical Technology Europe was established 20 years ago, PAT was not a hot topic in the industry. It was started in 2002 by FDA to modernize pharmaceutical manufacturing and increase the efficiency of manufacturing processes.

20th Anniversary Special Feature: The time for process understanding

Practical guidance on how to handle validation failures cannot be found in the existing literature because they are not supposed to happen.

The recovery mission – coping with validation failures

A manufacturing line can be improved if technology transfer is implemented thoughtfully. Effective technology transfer helps to provide process efficiency and control and maintain product quality.

Technology Transfer Provides Manufacturing-Process Control

Essential components of a good inspection: good ingredients, proper inserts, and ... deer?

Vapors, Venison, and Videos

Jim Miller is president of PharmSource Information Services, Inc., and publisher of Bio/Pharmaceutical Outsourcing Report.

Most CROs are entering China with expectations that a significant local market opportunity will develop as major pharmaceutical companies establish research development operations there...

East meets West

Manufacturing facilities must be inspected by members of regulatory bodies. Howeverâ€¦ these bodies are woefully inadequate at performing the task.

Out of Africa: the pharma challenge

If not properly monitored, filters and plastic bags can keep back more than they should.

Holding Back

If at first the product fails, then inspect, inspect again

Process and Scaling