Quality Assurance/Quality Control

Sep 01, 2003
Pharmaceutical Technology Europe
In an interview earlier this year (Bio-IT World, April 2003), Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), stated that "The original intent of the rule (21 CFR Part 11) was to facilitate the introduction of electronic technology to the process of the US Food and Drug Administration (FDA) submissions, as well as manufacturing and production. Part 11 was created to provide common-sense guidelines on how to do in the electronic world what was previously done on paper. During the last 5 years, however, confusion regarding what is included in the regulation and how to enforce it was impeding the introduction of new technology. The rule had created exactly the opposite of what was intended."
Jan 01, 2003
Pharmaceutical Technology
By Pharmaceutical Technology Editors
A procedures system must be well designed and managed to be effective and efficient.
Jun 01, 2002
Pharmaceutical Technology
By Pharmaceutical Technology Editors
A new set of proposed GMP standards for excipents may present more problems than benefits.
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