Standards/Regulations

Apr 01, 2003
Pharmaceutical Technology Europe
During autumn 2001, a Delphi survey was conducted using the Internet to discover the opinions of European experts from the pharmaceutical fields of industry, regulation and academia regarding pharmaceutical process validation. The Internet Delphi method was found to be an appropriate tool for exploring the opinions and experiences of pharmaceutical manufacturing because it allowed anonymous participation and discussion between geographically dispersed parties. However, to obtain reliable results, many factors were taken into account, as this article examines.
Apr 01, 2003
Pharmaceutical Technology Europe
The US Food and Drug Administration is making changes in inspection processes, post-approval manufacturing changes and 21 CFR Part 11 policies to streamline oversight and improve product quality.
Mar 02, 2003
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Pharmaceutical science & technology news.
Mar 02, 2003
Pharmaceutical Technology
Concerns about the safety and efficacy of dietary and herbal products are generating manufacturing requirements and analytical standards for ingredients.
Mar 01, 2003
Pharmaceutical Technology Europe
The renewal of European regulations regarding pharmaceutical process validation in autumn 2001 has been the subject of much discussion. The purpose of this article is to summarize and review the development of pharmaceutical process validation, and demonstrate how industry opinion regarding the concept has shifted from that of a regulatory burden to something driving total quality management and cost benefits.
Mar 01, 2003
Pharmaceutical Technology Europe
By Albedo
Brussels report
Mar 01, 2003
Pharmaceutical Technology Europe
As the US Food and Drug Administration (FDA) strives to streamline its regulatory process for bringing new drugs to market (see sidebar "Manufacturing data key to spurring drug development"), efforts to ensure the quality, safety and efficacy of dietary supplements and herbal medicines are gaining more attention.
Feb 02, 2003
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Pharmaceutical science & technology news.
Feb 02, 2003
Pharmaceutical Technology
Health experts are recognizing teh need to plan for global manufacturing of new treatments for AIDS and other diseases.
Feb 01, 2003
Pharmaceutical Technology Europe
Progress in developing AIDS vaccines is focussing attention on the challenges involved in producing millions of doses for developing nations.
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