Standards/Regulations

May 01, 2003
Pharmaceutical Technology Europe
Regular update from Washington.
May 01, 2003
Pharmaceutical Technology Europe
For nearly 40 years, drug dossiers have supported the quality, safety and risk/benefits of medicinal products. However, electronic technological advances mean that the dossier will soon be a thing of the past - being replaced by e-documents that can be reviewed and approved online by regulators, under the scrutiny of patient groups and with the final blessing of purchasers, as this article examines.
May 01, 2003
Pharmaceutical Technology Europe
By Albedo
Europe's pharmaceutical R&D has recently come under a barrage of criticism. Nobel laureate, Kary Mullis, highlighted the issue of over-legislating biotechnology and the business industry expressed its dismay concerning the EU's overly cautious approach to any kind of development. Action is needed before the sector's future resembles the plot of a Shakespearean tragedy.
May 01, 2003
Pharmaceutical Technology
By Pharmaceutical Technology Editors
The authors describe the solicitation of industry input for the guidance through a process that included a 2002 meeting of the Advisory Committe on Pharmaceutical Science and the subsequent formation of the PQRI Aseptic Processing Working Group.
Apr 02, 2003
Pharmaceutical Technology
FDA's newly launched risk-based approach to GMP regulation spurs signficant changes in the agency's approach to inspection processes, postapproval changes, and 21 CFR Part 11 enforcement.
Apr 02, 2003
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Pharmaceutical science & technology news.
Apr 01, 2003
Pharmaceutical Technology Europe
The pressure on the pharmaceutical industry to manufacture products faster and more cost-effectively has never been greater. Additionally, companies must also meet stringent regulations set by authorities such as the US Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA). This article explores the importance of complying with regulations and validation, how to maintain compliance and looks at some of the consequences of non-compliance.
Apr 01, 2003
Pharmaceutical Technology Europe
By Albedo
By its own admission, as the European Union tries to keep pharmaceutical and biotechnology development moving in the right direction, things are not going exactly to plan. With companies cancelling research projects at an alarming rate, it is politics, yet again, that is clouding the main issues of research and financial resources. And increasing pressure from the US isn't making life easier.
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.
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