OR WAIT null SECS
March 02, 2006
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.
Madness in March: lost ingredients, missed lot numbers, and a million-dollar photo.
Analytical tools and methods that require less water and detergent are gaining interest for faster, more efficient cleaning.
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.
February 24, 2006
Warning Letter: Southern Meds
February 02, 2006
"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.
February 01, 2006
Extractable and leachable issues should be resolved early in the drug manufacturing process. Open communication is imperative for a successful study.
January 01, 2006
A particular dermatological product was packaged in a metal tube, which is filled from the bottom.
December 14, 2005
FDA issues a warning letter to Nephron Pharmaceuticals.
December 02, 2005
To qualify and validate a pharmaceutical manufacturing facility, one must carefully review the facility design for compliance with good manufacturing practices and manage project scope definition, labor and cost estimating, and master-plan development.These activities, properly implemented, help deliver a validated facility on schedule, at the estimated cost, and with expected quality.