iSpeak Blog

Quality Systems: Lifecycle from Development to Discontinuation


The Third Annual ISPE-FDA CGMP Conference, held in Baltimore, Maryland 2-6 June  2014, opened on Monday, 6 June  with welcoming greetings offered by ISPE President and CEO Nancy Berg who introduced co-conference organizers Joe Famulare, vice president, Global Compliance and External Collaboration, Genentech, Inc. and Thomas Cosgrove, JD, acting director, Office of Manufacturing and Product Quality, FDA/CDER/OC/OMPQ.

Famulare thanked attendees from both industry and the FDA for their attendance and introduced Cosgrove, who recently assumed his position. Cosgrove told attendees that he would focus his efforts in such a way as to “maintain the integrity of the approval system” and to mitigate risk to patients. “I believe that enforcement should be consistent and predictable and that we should be ready and able to take enforcement action when needed,” said Cosgrove.  “This is a challenging time to be working in drug quality and we know that quality problems can lead to drug shortages. We also know that outsourcing is not without risks and that the risks may be hard to manage and present a risk to your firm.”

Mary Oates, PhD, vice president, Global Quality Operations, Pfizer, who spoke in the Plenary Session on “Implementing and Measuring a Culture of Quality,” discussed three important aspects of “Quality Culture” – Basic Compliance, Robust Quality Systems and a Control Structure/Quality System. She cited two important Pfizer principles: first, each individual and all employees from CEO to plant manager to the individual workers, must take ownership of quality performance and, second, business needs should not drive patient-based quality decisions. “The focus on putting patients first must come from leadership,” said Oates. “Leadership defines the values and where resources are deployed and how people are rewarded.”

Janet Woodcock, MD, director FDA/CDER, talked about “evolution” in FDA regulation, “where are we going,” and she suggested that we need to get away from a ‘culture of complaints’ and get to a ‘culture of quality.’  FDA, she told attendees, is in the process creating new offices in an effort to develop a “single quality assessment,” and also developing an IT platform to create a large and comprehensive database to get more and better information on facilities and their individual statuses in order to generate “risk scores.” “We also want to reduce excessive documentation,” she said.

An all-conference session, moderated by Russ Wesdyk, FDA/CDER/OPS, provided an overview on the Metrics Implementation initiative, and introduced the panel members who served on the ISPE team, formed last year, to address developing a program for quality metrics. He discussed the timeline of efforts since the initiative started at last year’s ISPE-FDA CGMP conference, which included delivering a white paper that resulted from an industry survey on the variety of metrics firms use to measure quality as well as recent discussions on metrics held at the Washington, DC-based Brookings Institute. “We want to choose the right metrics,” said Wesdyk, who added that the chosen metrics needed to robustly support Q 10.

Presenting information from a metrics initiative in China, Qiang Zheng, PhD, professor and director of the Center for Pharmaceutical Information and Engineering Research at Beijing University, China, discussed results of a survey given by his graduate students. He reviewed the data they collected on product quality complaints and production capabilities as well as the respondents’ ideas about frequency of inspections and, among other issues, how many felt about quarterly, biannually or annually visits from regulators were preferred.

Diane Hagerty, Head of Global Quality Systems and Processes, Genentech, Inc. reported on the progress of the Quality Metrics Team formed at the 2013 ISPE-FDA CGMP Conference. The team was charged with developing a program to achieve consistency in metrics; finding metrics that truly reflect quality; and determining the metrics to be applied to sites versus those applied to products. With the survey of sites completed, the project is moving to a pilot stage.  The ISPE Quality Metrics Pilot Program aims to establish a confidential database with blinded comparisons with many different types of participating companies that produce a wide range of technologies, Hagerty explained.

Participants in the Metric Implementation Panel Discussion, moderated by Bill Paulson, editor-in-chief, International Pharmacy Quality, followed-up on the progress of the project details presented by Hagerty with discussion and questions fielded from the floor. Paulson asked the panel about the differing paradigms of industry and regulators represented by “blind compliance,” lack of transparency, a status quo mentality fostered by blind compliance, and efforts to focus on the patient. “It is a challenge to move from ‘blind compliance’ to a focus on the patient and an even broader focus on quality,” agreed Wesdyk.  “But we think metrics can help by turning data into knowledge - metrics is a tool.”

Fran Zipp, president, Lachman Consulting, added that “metrics can’t hurt” if they provide transparency. Questions from the floor included those about the confidentiality of the data collected and questions about is quality measurable and how can quality be measured? Wesdyk suggested that while the data was confidential, firms could publish their own data if they wished. On the questions of “is quality measurable and what will be done with the data?” Zipp suggested that one should “not collect data unless you know what you are going to do with it.” Hagerty noted that the purpose of the survey was to see what kinds of metrics were being used by the industry and choose the “right metrics” from those being currently used


Pinnacle 2014