26.11.2019 | LOGFILE Feature 44/2019

PDA/FDA Joint Regulatory Conference 2019

PDA/FDA Joint Regulatory Conference 2019

6 min. reading time | by Thomas Peither


The PDA/FDA Joint Regulatory Conference in September in Washington, DC, was once again an important meeting place for the pharmaceutical industry this year. Topics ranged from regulatory updates, quality aspects, compliance challenges, new technologies for manufacturing, laboratory and quality assurance to control strategies, facility life cycles, inspection strategies and audit effectiveness.

The conference covered a broad range of various quality aspects relevant to the pharmaceutical manufacturers. For this article we followed the lectures of Patricia Cavazzoni and Jackie Elbonne on September 16, 2019 with great interest.

„The executive management is the most single aspect to reach a quality culture!“

Patricia Cavazzoni, U.S. FDA representative, emphasised the importance of quality systems and quality aspects. Drug innovations must go hand in hand with investments in quality systems, according to her credo. She underlined the role of the FDA, which has been continuously in place since the FD&C Act Amendment of 1962, "The CDER ensures that safe and effective medicines are available to patients".

From her point of view, the quality culture is still neglected in many companies. "Management is the most important factor in achieving a quality culture,"said Cavazzoni. In particular, the behaviour of managers plays a decisive role in a strong quality culture. A powerful quality assurance does not end at the gates to the company headquarters, but is also represented there with a powerful voice. Here she referred to the global supply chain, which is usually controlled there. "If a supplier does not follow the same quality culture philosophy, he will be a weak element in the supply chain." The FDA sees great potential for further development in the implementation of a consistent quality culture. "A solid quality begins and ends with the training of people." And with this statement Cavazzoni certainly meant all employees from top management to the production line.

A performance-based quality management system is also essential for the further development of quality. "The pharmaceutical industry is far behind the process understanding of other industries, such as the semiconductor and automotive industries," Cavozzi noted critically.

However, she also mentioned the fact that the FDA must also develop further and pursue important tasks. For example, she mentioned the FDA initiative NIPP (New Inspection Protocol Project), which initially refers to sterile manufacturing sites. "There is increasing need to more efficiently collect and analyse the information we gather during inspections to give us even better and timelier insight on the state of quality in drug manufacturing facilities and promote the relevance of this information to our regulatory decisions," FDA Commissioner Dr. Scott Gottlieb said in the November 2018 FDA press release when he announced the initiative. The project is based on experience with previous projects since 2014.

Cavazzoni, in response to questions from the auditorium, informed that the protocol on which NIPP was based was not yet publicly available. The industry questioners noted that it would be very helpful for industry to have access to the content of the programme. Cavazzoni stressed that with NIPP, a systematic approach is being implemented that is also being intensively communicated to the inspectors initially.

„It is a never-ending journey!“

The second lecture in the plenary session was given by Jackie Elbonne, Chief Quality Officer and Senior Vice President, Global Quality at Bristol-Myers Squibb (BMS). She talked about the Lifecycle Approach to Quality Excellence. First she described the challenges of her company with 14 production sites worldwide, 70 target countries and more than 100 partners for 47 products.

In the visualisation of the quality vision - GxP lifecycle approach - she pointed out the goals for the company and its employees. BMS has been on this path for two years now - and there is no end in sight, "It is a never-ending journey! “

Elbonne especially emphasised the clarification of process ownership. The process-ownership structure hast to be clearly defined, communicated and filled with life.

She presented three case studies to the interested audience. In the first case study, she showed an improved approach to process monitoring. This resulted in a significant reduction of variabilities and a higher robustness of the processes. In process monitoring, BMS identified areas for improvement at an early stage and quickly made decisions on improvement measures.

The figure shows the improvements very clearly.

In the second case study she showed the positive correlation between improved product quality and the reliability of supply security and faster patient care. Important buzzwords were:

  • Robustness
  • Root cause analysis
  • Process understanding
  • Process control
  • Investigations
  • Review Board

The efforts were rewarded with:

  • Reduced cycle times
  • Lower cycle costs and
  • Fewer examinations

Thus, activities both in administration and on the line were reduced – a great success for all involved.

The third case study looked at the construction of a new manufacturing facility in Cruiserath, Ireland with an investment of approximately USD 1 billion. Here a state-of-the-art facility for biological products was built. QbD concepts were consistently applied in order to implement the best possible processes right from the start.

In her lecture, Elbonne also stressed the importance of the quality culture and thus the commitment to a culture of quality excellence. "Building a culture of quality excellence is a long-term organisational commitment built on a foundation of capabilities, tools and knowledge management.”

„It starts to be meaningful for excecutive levels!“

In the discussion that followed, Elbonne stressed that it was important to define the costs of quality and non-quality. These costs would often lead to a rethink in management - because quality can thus be better assessed in an entrepreneurial context.


Cavazzoni, Patricia, PhD; PDA/FDA Joint Regulatory Conference; September 16, 2019; Washington, DC
Elbonne, Jackie, PhD; PDA/FDA Joint Regulatory Conference; September 16, 2019; Washington, DC

Thomas Peither


Thomas Peither
Dipl.-Ing. (Univ.) Mechanical Engineering
E-Mail: thomas.peither@gmp-publishing.com


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