OR WAIT null SECS
October 28, 2010
The US Food and Drug Administration issued a draft guidance last week on the Qualification Process for Drug Development Tools.
October 02, 2010
From disagreement to denial, being cordial about quality control can be challenging.
September 02, 2010
From weekend deliveries to nonsterile gloves, a single exception can make a product fall flat.
August 19, 2010
The US Food and Drug Administration and European Medicines Agency (EMA) are looking for drug manufacturing companies to participate in their joint good manufacturing practice (GMP) inspection pilot program.
August 02, 2010
Fallout escalates from McNeil recall and Genzyme shortages as regulators review oversight.
Cases of overlooking proper packaging, reconstitution, directions, and dissolution.
August 01, 2010
The recent amendment to Annex 1 has seen controversial changes relating to the capping of vials.
New isolator and disposable technologies are set to assume a greater role in pharma manufacturing, according to a recent conference in Germany.
July 09, 2010
Changes to Part 2 of the EU GMP guide will come into force by 31 July 2010 in order to bring it in line with the ICH Q9 guideline on Quality Risk Management. As a result, it will no longer be identical to the ICH Q7 guideline on APIs - a harmonised guideline for the US, Europe and Japan.
July 02, 2010
Reports of overlooked controls, dropped pallets, and misplaced documents leave a chill in the air.