OR WAIT null SECS
August 02, 2009
An ounce of contamination usually leads to a mountain of investigation.
July 02, 2009
Some GMP agents seem to find a way to squander time, money, and common sense.
June 02, 2009
Short-term problems in software or hardware lead to long-term manufacturing troubles.
June 01, 2009
In 2005, a small delegation (myself included) of the European Fine Chemicals Group (EFCG) met with the deputy head of the cabinet of Commissioner Kyprianou (the then Commissioner responsible for health and consumer protection). Our mission was simple - we were there to raise a red flag.
Today, approximately 1.5 million counterfeit medicine packs enter the legal supply chain each year - in other words, one pack in every 20000 is counterfeit.
May 02, 2009
Process steps, GMP documents, a purification vessel, and validation seem to disappear.
May 01, 2009
With a new head of the FDA expected to be announced imminently, the pharmaceutical industry waits to witness the changes that will inevitably accompany the new appointment. These changes could, however, also impact the rest of the world's pharmaceutical markets.
The author reviews the draft guidance on process validation, its QbD applications, and its potential impact on sterile manufacturing operations.
April 02, 2009
GMP agents report on old products, aseptic violations, and unexpected emotions.
April 01, 2009
Operational excellence awaits, but only if you can implement PAT successfully.