September / October 2017

Quality Manufacturing Conference: Aligning with Regulatory Priorities


This is an important event for quality professionals," said Marianne Bock, ISPE’s director of continuing education, describing the fifth annual ISPE/FDA/PQRI Quality Manufacturing Conference, held 5–7 June in Arlington, Virginia, United States.

"This year’s program was developed jointly by a team of FDA regulators and industry quality experts. Content was driven by priorities of both industry and FDA’s Office of Pharmaceutical Quality (OPQ) to focus attention on significant issues facing both entities," she continued.

In response to attendee feedback, the event had a new format that was built around four interactive workshops, with topics chosen from the FDA’s priority list for 2017: Linking Quality to Clinical Relevance, Modernizing Pharmaceutical Manufacturing through Emerging Technology and Innovation, Designing Proactive Approaches to Facility and Life Cycle Quality Management, and Implementing Next Steps for Quality Metrics.

Workshop sessions were designed to encourage frank discussion and identify real solutions to current challenges. Following a short introduction, participants broke into groups to share perspectives, explore best practices, and discuss the future of these important initiatives.

"The workshops allowed for a very high level of engagement among delegates, industry leaders, and regulators," said Bock.

Aligning With Regulatory Priorities

Data Integrity Workshop

"Control of your data is the foundation of all pharmaceutical manufacturing processes," said Frances Zipp, President and CEO, Lachman Consultant Services, as she welcomed attendees to the Data Integrity Workshop, a special half-day event held on Sunday, 4 June.

Following Zipp’s opening remarks, Michael Rutherford, Consultant–Laboratory and Quality Systems, Medicines Development Unit, Eli Lilly and Company, and Data Integrity Program Committee member, presented an overview of the new ISPE GAMP® Records and Data Integrity Guide (published April 2017), which includes sections on regulatory focus, data governance framework, and quality risk management.

After the opening plenary, attendees divided into three breakout groups: Process Workflows and Data Mapping, Data Review and Forensic Tools (with one session focused on Laboratory and one on Manufacturing), and Data Integrity Governance Maturity Model and Cultural Model.

"This was the second year the Data Integrity Workshop was held in conjunction with the Quality Manufacturing Conference," said Rutherford, "and this year we focused on providing tangible tools that taught skills the participants could take back to their companies and apply. We listened to their feedback from last year and really tailored the program to meet their needs."

The workshop concluded with a regulatory and industry panel discussion led by Stephen Mahoney, Senior Director in Global Quality and Compliance at Genentech, Inc. The workshop leaders were by FDA representatives Sarah Barkow, PhD, Team Lead, Manufacturing Quality Guidance and Policy Staff at CDER’s Office of Manufacturing Quality, and Karen Takahashi, Senior Policy Advisor at CDER’s Office of Policy for Pharmaceutical Quality.

"One topic that really sparked a lot of discussion," said Rutherford, "was oversight for third parties and the importance both parties play in ensuring data integrity. This linkage and the importance of managing our suppliers and third parties was further emphasized by Thomas Cosgrove during his keynote presentation during the conference." Other questions included quality assurance periodic review, how firms can improve data integrity, what companies should look for when auditing suppliers, and how to prepare for an audit.

The bottom line, Rutherford concluded, is that "the bulk of data integrity problems occur where technology and people intersect."

    Participants in each session interacted with industry experts
    “Participants in each session interacted with industry experts and regulators who led the discussions, working with each group to answer questions and share best practices.” Key findings and results from each topic were presented by the facilitators and regulators during the Workshop Reports on the final day of the conference.


    Attendee Feedback

    • The process mapping session was extremely informative and very interactive.
    • I am convinced that by understanding and preventing data integrity events across the entire supply chain, we not only enable our companies to deliver the life-enhancing, life-saving therapies we make to our patients more efficiently, we reduce drug shortage risks.
    • Panel discussion with FDA and industry experts allowed opportunity to interact, understand the current thinking and enforcements from regulatory agency

    Keynote Review OPQ Progress Update

    George Millili, Senior Principal Technical Advisor, Genentech, and Conference Planning Team Chair, 2017 ISPE/FDA/PQRI Quality Conference Program Committee

    This annual conference is one of the most important conferences of the year. Cosponsored by ISPE, FDA, and PQRI, it allows many opportunities to interact with FDA regulators. Dr. Michael Kopcha, Director, Office of Pharmaceutical Quality, FDA, CDER, presented an informative keynote entitled "OPQ Progress Update." Some of the highlights were:

    • The new OPQ structure has been operational for a year; he feels that there has been improved oversight of quality throughout the quality life cycle.
    • He commented on the agency’s successful efforts to reduce redundant inspections by the various FDA offices. They accomplished this by clearly outlining roles and responsibilities of each FDA group in detail, and by enhancing the communication process of all involved.
    • The New Inspection Protocol Project is standardizing how inspections are performed so industry better understands agency expectations.
    • He thanked industry for its comments on the draft Quality Metrics Guidance. The FDA took them seriously, he said, and incorporated many of the suggestions into the second draft. Once all the comments have been reviewed more interaction and discussion will be required on how to implement this guidance and standardize definitions.
    • He encouraged the development of emerging technologies and underscored the importance of early communication with the FDA emerging technology team when working with a novel or innovative technology. A good number of companies are already doing this, and he encouraged more of these interactions.
    • "Like any other organization, we need to continuously improve," he concluded. "We’re working together to achieve the vision of ‘a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drugs without extensive regulatory oversight.’ The key is ‘without regulatory oversight.’ We need to advance manufacturing sciences to know that quality issues have been addressed. Review must be done on a risk-based basis. Hopefully this dream will be realized in my lifetime."

    If you have not had the opportunity to attend one of these conferences, I encourage your participation next year. This is a simple way to remain current with FDA and industry priorities, expand your professional network, and enjoy spending time with colleagues, both during the sessions as well as in the numerous breaks and receptions.

    Participants in each session interacted with industry experts


    A Workshop Leader's Perspective

    James McGlade, Science Market Leader BHDP Architecture

    When I was first asked to be a workshop leader for the Quality Manufacturing Conference this past June, I accepted thinking my workshop assignment would be directly related to my professional field of architecture. Instead, I was completely out of my comfort zone as I helped guide the Facility and Lifecycle Quality Management Workshops—assisted by a team of "true" experts in the field, thank goodness!

    I fully expected to learn more about an area of the manufacturing process of which I had only a cursory knowledge. By the end of the two-day conference, however, I had two other unexpected learnings for which I could see parallels in my sphere of influence.

    First, multiple attendees noted that a "supportive management culture" is critical to finding true root causes to errors. If the goal is to always find a person to blame, I realized, then the truth will always be difficult to find. A supportive culture allows for a team approach to discovery and learning rather than

    avoiding what is true to evade any repercussions. This is also a reality when dealing with facility design and construction. A collaborative and mutually supportive team always provides improved results.

    My second takeaway was discovering that knowledge transfer of consequences to operators is critical. In my world, "operators" would be the equivalent of design architects and engineers, but in both spheres, these are the people on the front line of effort. Their day-to-day responsibilities can have an enormous influence on product outcome—patient safety in the biopharma world. Ensuring that potential process consequences are effectively communicated was a discussion theme that emerged repeatedly.

    The Quality Manufacturing Conference was a unique experience for me. The workshop format created two days of energetic discussions while I gained a deeper understanding of what quality management entails. Many of the conference attendees I spoke to also told me they had gained new ideas and perspectives that they can incorporate in their organization’s quality approach.


    Women in Pharma Breakfast

    Women In Pharma Breakfast

    Conference participants gathered for the Women in Pharma (WIP) breakfast on Tuesday, 6 June. Chair Fran Zipp, President and CEO, Lachman Consultants and ISPE Board Member, welcomed more than 100 attendees.

    "Women in Pharma began as a small idea for the ISPE Annual Meeting last year," she said. "The response was terrific so we decided to formalize the group, and here we are."

    Emily Stump, Director of Operations, Pacific Northwest, Commissioning Agents, Inc., introduced

    the panelists and facilitators: Mihaela Simianu, PhD, Director, Regulatory Compliance, Pharmatech Associates, Inc.; Kellie Schoolar Reynolds, PharmD, Deputy Director, OTS/OCP/DCPIV, US FDA, Center for Drug Evaluation and Research; Tammie Champlin, Senior Director, Quality Engineering, Johnson & Johnson; and Valerie Jensen, Capt., RPh, Associate Director, Drug Shortage Staff, US FDA.

    The event began with a panel discussion on the characteristics that lead to success and career-defining or pivotal events. Table discussions on assigned questions followed, after which Zipp asked for a volunteer to share each group’s summary.

    In her closing remarks Zipp thanked ISPE CEO and President John Bournas and Board Chair Mike Arnold for their support, and expressed gratitude to sponsors Johnson & Johnson and Pharmatech.