ucm275340_Janet_Wooodcock Dr. Woodcock spoke on a variety of issues regarding company quality culture and quality metrics, but began with a “thanks” to ISPE for embarking on a mission to bring quality metrics to the industry. “You are helping us,” she said.

“Building a quality culture begins with a goal,” Woodcock told attendees.  She reviewed the growing interest in “quality” since the 1980s and suggested that the goal of what she called the “quality revolution” is to bring a “critical product to the customer that each time has consistent qualities.” This requires robustness and reliability, and that means using metrics to make it happen.

“We are dedicated to protecting the health of the public,” said Woodcock. “That is our goal.”

She also spoke on having a company quality culture that allows employees to speak up when they see something wrong and that employees should not live “in a state of fear” when wanting to speak up.

Her discussion of fear and a quality culture then turned to what she described as a “fundamental issue” between the industry and the FDA – that is the fear that industry has of the agency. The FDA is not going to attempt to “nail” people, she promised.

“This is a huge problem – I didn’t make this up about fear,” she said, and referred to questions that had been raised around “what will the FDA do with the reports generated by using quality metrics?” She asked “How do we get to a better place where quality is not equated with a lot of inspections? How do we decrease inspections? We can reduce them by having a standardized and robust system of quantitative measures that we can trust. I don’t want quality metrics to increase the fear factor.”

Woodcock posed a fundamental question. “What is the state of pharmaceutical manufacturing in the U.S. now?” She said that she didn’t know, but needs to find out.  One problem, she noted, was that the industry was so spread out in terms of the varieties of products (generics, OTCs, CMOs), and also with non-U.S.- based manufacturing sites about which FDA did not have adequate information.

“Without standard measures we can’t get to a system in which we have trust,” she concluded.