Standards/Regulations

Aug 02, 2003
Pharmaceutical Technology
Manufacturers face challenges from FDA's plans to streamline the drug review and development processes aimed to spur innovation.
Aug 01, 2003
Pharmaceutical Technology Europe
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.
Aug 01, 2003
Pharmaceutical Technology Europe
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.
Aug 01, 2003
Pharmaceutical Technology Europe
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.
Jul 02, 2003
Pharmaceutical Technology
Biotech firms face new issues as FDA weighs policies to streamline generic-drug approvals and reduce patent disputes.
Jul 02, 2003
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Pharmaceutical science & technology news.
Jun 02, 2003
Pharmaceutical Technology
FDA's plan to establish pharmacogenomic policies spurs concerns among manufacturers, particularly in regard to how the policies will affect new-drug testing and approval.
Jun 02, 2003
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Pharmaceutical science & technology news.
Jun 01, 2003
Pharmaceutical Technology Europe
This article examines the application of 21 CFR Part 11 to those areas of research and development (R&D) where compliance is not strictly required and the response of R&D equipment vendors to the rule's requirements and customer needs. The case is presented that vendors must accept that understanding and meeting Part 11 requirements is now part of their business environment.
Jun 01, 2003
Pharmaceutical Technology Europe
Good laboratory practice (GLP) regulations became effective in 1979 under 21 CFR Part 58 and apply to all non-clinical safety studies intended to support research permits or marketing authorizations. This article introduces some key elements regarding the application of GLP regulations as a quality system and how GLPs are perceived internationally.
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