Pharmaceutical Technology-12-02-2006

This article describes the design and development of a material-sparing fluidization segregation tester for use with pharmaceutical powders. This tester offers several improvements over the current ASTM standardized test practice. Less than 20 mL of material is required to characterize the fluidization segregation potential of a sample. Features of the tester include powder containment for potent compounds, in-process monitoring of the fluidization conditions, and sample retrieval without the need for subsampling or riffling for typical analyses.

As salaries stagnate and FDA's initiatives play a bigger role in the job environment, the pharmaceutical workforce keeps its eyes on the future.

Brand-name manufacturers seek to protect their products.

Poor support of drug- and process-development training programs will affect industry's future growth.

Pharmaceutical companies ally with specialty companies and research organizations to advance biocatalysis.

The US Pharmacopeia (USP), the Japanese Pharmacopoeia, and the European Pharmacopoeia "Microbial Limits Tests" are in the final stages of harmonization. The harmonized USP chapters are slated for implementation in 2009. This article describes the harmonized USP Chapters <61> "Microbial Enumeration," <62> "Absence of Specified Microorganisms," and <1111> "Microbiological Attributes of Nonsterile Pharmaceutical Products," and suggests they will likely require some revalidation of existing methodologies. Companies should put plans in place immediately for this work and show consistent progress towards this goal.

Makers of injectable drugs can increase their market share and stay competitive by devising a product life-cycle management strategy.

We really knew what we were doing-until we opened the column for a routine repacking.

The integrated services model is the "next big thing" in CMC and early development services.

Proof of concept is a new development paradigm.

Years of concentrating its political support on one side of the political spectrum may have eroded the industry's ties to the new majority.