Pharmaceutical Technology Europe-08-01-2003

European expert opinions regarding pharmaceutical process validation were collected and studied by performing an Internet Delphi survey. In total, 36 experts from 10 countries representing the pharmaceutical fields of industry, regulation and academia participated in the survey. The overall attitude to process validation appeared to be positive; however, a number of concerns were raised. More education, better use of prioritizing tools and increased evidence of cost-effectiveness is needed to further develop and facilitate process validation.

In December 2002, FDA notified DMV International that its pharmaceutical lactose manufacturing facility in The Netherlands had passed inspection. It was only 3 years earlier that DMV had started an ambitious programme to implement cGMP for API production conforming with ICH Q7A guidelines.

During the last few years, it has become increasingly apparent that many large pharmaceutical companies are moving their research and development operations to the US, leaving Europe with increasing numbers of smaller companies. This article briefly examines the possible motives for relocation, including the impact of regulation differences between the US and Europe.