Drug Development

Articles

Vitamin D and a sunny window shed som light on product stability.

On the Bright Side

All sectors of manufacturing are under continual pressure to bring new products to market quicker, stealing a march on the competition and maintaining their revenue stream.

Computer system validation ? increasing supplier value

Adding a cleaning step to the field-testing protocol, and combining it with the data generated to register sanitizing and disinfectant agents under FIFRA and the CEN TC 216 work program, produces a sanitation-and-disinfection validation methodology that is cost-effective, simple, and time-saving.

What is Disinfectant Validation?

Madness in March: lost ingredients, missed lot numbers, and a million-dollar photo.

Mysteries and Mishaps

Analytical tools and methods that require less water and detergent are gaining interest for faster, more efficient cleaning. 

Pursuing Efficiency: New Developments in Cleaning Technology

Because of the growing popularity of single-use materials, the identification, characterization, and qualification of new materials used for disposable processes have become increasingly important for both regulatory and production purposes. This article describes one approach to identifying and validating the materials used in a disposable filling process.

Characterization, Qualification, and Validation of a Disposable Final Filling Process for Parenteral and Ophthalmic Drugs

Warning Letter: Southern Meds

"It was the late 1970s," reports our GMP-Agent-in-Place, "and we used a primitive desktop computer with built-in teletype for our quality control work.

Sweet Mix-ups and Sour Data

Extractable and leachable issues should be resolved early in the drug manufacturing process. Open communication is imperative for a successful study.

Identification and Risk-Assessment of Extractables and Leachables

A particular dermatological product was packaged in a metal tube, which is filled from the bottom.

Process and Scaling