What Does A New FDA Quality Office Mean?
By Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.
The news that the FDA is creating a new Office of Pharmaceutical Quality probably set off the alarm bell for the industry. Does a new quality office mean new requirements? It’s the first question that comes to mind.
And FDA Commissioner Margaret A. Hamburg was very good about anticipating the question when she talked about the new office. “Let me emphasize that we’re not talking about new quality requirements,” she said at the annual conference of the Generic Pharmaceutical Association earlier this year. “Our current GMP regulations have been in place for decades; there have been no recent changes that would substantially impact requirements for product manufacturing.”
That’s great news; now everybody can relax! The next logical question is: If the new quality office doesn’t mean new requirements, then what exactly does it mean? “We’re talking about complying with existing ones [regulations],” said Hamburg, who emphasized the importance of quality throughout her speech.
So enforcement— not new requirements— is what the new Office of Pharmaceutical Quality is all about. Its establishment signals the FDA’s renewed focus on quality and continuous quality improvement.