The QA Pharm
Like anyone else, when I plan for the new year, I need to set aside time for reflection and anticipation. I look back and ask, “Have I made a difference in anyone’s life?” I look forward and ask, “...
The QA Pharm
Most good manufacturing practices (GMP) training that I encounter is not necessarily bad, just irrelevant. In fact, the same could be said for most training departments. They jealously guard their...
The QA Pharm
The cover of Fortune magazine popped off the newsstand shelf last week [Aug. 15, 2011] with the article, “What Happened at Pfizer: The Inside Story of Revenge, Betrayal, and Power at the Top of the...
The QA Pharm
The truism, “Quality, cost, and speed—pick two,” was often quoted throughout my career: meaning a production company could not achieve all three ideals and therefore must choose which two out of...
The QA Pharm
Responses to the Food and Drug Administration’s (FDA) Warning Letters and the FD483—a written notice of deficiencies found during inspections—are usually full of commitments. They involve what...
The QA Pharm
Just when you think that the Food and Drug Administration (FDA) has to stick to the script by quoting chapter and verse of current Good Manufacturing Practices (CGMPs), it gets very progressive and...
The QA Pharm
Once upon a time I asked, “What does it mean to operate in a state of control?” at an off-site “strategy” meeting of a senior management group. You know the kind of meeting that I'm talking about—one...
The QA Pharm
Can you imagine the stream of firms that venture into their respective FDA district offices to give presentations on their warning letter response and to offer their assurance that they truly “get it...
The QA Pharm
A March 30, 2011, Food and Drug Administration (FDA) Warning Letter to Ningbo Smart Pharmaceutical Co. revealed that it had reported conformance to specifications on certificates of analysis, when in...
The QA Pharm
By the time a consent decree comes along—which happens when a firm repeatedly violates current good manufacturing practice (cGMP) requirements and the Food and Drug Administration (FDA) forces it,...
