Standards & Regulations

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.
Jun 01, 2003
Pharmaceutical Technology Europe
The US Food and Drug Administration is working with manufacturers to establish new policies for incorporating genomic information into the regulatory process and simultaneously encourage pharmacogenomic research.
May 02, 2003
Pharmaceutical Technology
FDA resolves the bar code labeling debate, releases its GMP requirements for dietary supplements, and proposes a comprehensive adverse-event reporting system.
May 02, 2003
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Pharmaceutical science & technology news.
May 01, 2003
Pharmaceutical Technology Europe
On 20 February 2003, the US Food and Drug Administration (FDA) published a new draft guidance relating to 21 CFR Part 11. The new guidance mainly affects the compliance requirements of systems with a low risk and low impact on product quality; however, systems with a high risk and high impact on product quality, such as chromatography data systems or laboratory information management systems (LIMS), remain unaffected, as this article describes.
May 01, 2003
Pharmaceutical Technology Europe
Regular update from Washington.
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