Quality Assurance/Quality Control

A radiotracer technique is a simple, fast, and sensitive technique for analyzing the integrity of clinical supply packages to water.

Glossary of computer and software terms.

As newer and more elaborate hardware and software systems are installed in automated manufacturing environments, companies are further incorporating good practices into their validation process.

Analytical instrument suppliers are developing manufacturing-tailored tools that are small, precise, and easy to use.

A straightforward approach reveals how the probability of passing the USP content uniformity test can be calculated for tablets and capsules.

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."

A procedures system must be well designed and managed to be effective and efficient.

A new set of proposed GMP standards for excipents may present more problems than benefits.