Pharmaceutical Technology Europe-11-01-2004

The implementation of a total organic carbon (TOC) method into the United States Pharmacopeia (USP) has its origins in the early 1990s, when the Water Quality Committee (WQC) of the Pharmaceutical Manufacturers Association (PMA, later renamed PhRMA) debated improvements in the testing of purified water (PW) and water-for-injection (WFI). The resulting inclusion of modern analytical techniques replaced much older methods - some of which had been listed in the USP for more than 150 years. Finally, two new regulations were put in place: Chapter for conductivity, which replaced a series of individual ion tests; and Chapter which replaced the oxidizable substances test with a TOC method.

… the real glue that holds the partnership - and project - together, even more so than a formal contract or quality agreement, is the ability to communicate regularly and honestly with each other.

Granulation is one of the most important unit operations in the production of pharmaceutical oral dosage forms. However, there are many different technologies each having different strengths and weaknesses. Most companies choose which one to use simply based on their own experience. This article introduces different processes, compares them objectively and offers unbiased advice on the merits of each system. It then looks at the implications of selection on two different applications.

A big problem for the industry seems to be that Phase II has become something of a 'black hole' for drug development; new drug candidates can't seem to escape once they enter.

Packaging machines for new or existing lines are easier to operate and change over than they ever were before. Today's packaging machines also accommodate a greater variety of heights, diameters, finishes, or dosage regimen counts.