11.10.2016 |

LOGFILE No. 38/2016 – PDA/FDA Joint Regulatory Conference 2016

Evolution and a Touch of GMP Revolution at the PDA/FDA JRC 2016

(Reading time 5 min + 3 min video)

by Thomas Peither

Biotechnology, continuous manufacturing, quality methods and digital transformation were among the topics of the most important GMP conference of this year. Approximately 1000 participants from industry and US authorities discussed the trends of the future. This included more than simply explaining the gentle course of further development. A touch of revolution, especially on the topic of digital transformation, sometimes rippled through the air-conditioned lower level of the Washington Renaissance Hotel. The most current topics from the FDA and the pharmaceutical industry were illuminated here.

The PDA/FDA Joint Regulatory Conference 2016 deservedly counted more visitors than any others of recent years. The 1000 participants and over 100 FDA representatives attending this conference, being held for the 25th time, demonstrated not only views held in common, but also conflicting challenges.

And a number of topics emerged that represent a challenge for both sides:

  • Biotechnology is clearly on the rise
  • Continuous manufacturing will drastically change production
  • Classic quality methods are gaining importance
  • Waiting for the digital game changer

Biotechnology becomes a driving force

Neither in the conference programme nor in the discussions during breaks could the fact be overlooked that biotechnology will completely transform the pharmaceutical industry. Not only will research and development and the approval of medicinal products have to be viewed from a different angle. The manufacture of preparations on a biotechnological basis has also changed drastically in recent years. Whereas in former times factories could be measured in terms of football fields, in the future they may even fit into a single transport vehicle. At the same time, quality and process reliability will increase significantly. What does this mean for GMP conformity? How can process reliability be achieved and batches released if, for example, products or vaccines are manufactured at scattered locations without a large staff? Is this even conceivable? What potential problems can arise?

It also became evident that within this market biotechnological production involves many new players who up to now have classified GMP as more of a research acronym than anything else. Therefore, industry representatives in this field feel that there is much catching up to do as far as GMP conformity is concerned.

However, the winds of change in these companies leave ample space for new ideas, and the conventional pharmaceutical industry will be able to learn a great deal if challenges are met with new solutions, efficiently and at low cost. For it is not an unshakable truth that quality departments have to be inefficient and oversized. Conventional wisdom says that start-ups are more likely to experiment than established businesses. We shall observe these companies closely and report again in due course.

For starters, here are some figures from a large biotech company:


Continuous manufacturing stirs up production technology

We have already reported on this modern production principle, which originated in the assembly line production of Henry Ford. Meanwhile, the automobile industry has perfected this concept. The chemical industry as well would not be able to offer such low prices without this production principle.

This is a top priority since processes must be reliable and under control. Proof can be provided by anyone using SixSigma considerations. Anyone who can substantiate such controlled processes should embark upon this adventure and consider continuous manufacturing. All others should attempt to optimize process reliability and process control of production methods.

What does the FDA have to say about this? The FDA does indeed see problems in judging continuous manufacturing with previous standards. This begins as early as in batch definition and limitation. And what about releases when shipping of the product could already be in progress while the last portion of the batch is still being processed? The FDA itself poses these questions and is open for discussion. The end of the discussion must remain open. We are already eagerly awaiting the answers to these complex questions.

Three cheers for the quality methods according to Deming, Shewhart, etc.

Are you not yet familiar with the names Deming, Shewhart, …? Then it is time to become acquainted with these protagonists of uncompromising quality. During inspections there could soon be demands for quality control cards and continuous improvement. Do you involve your co-workers in defining quality? Or is quality still defined in the higher echelons? Deming took another path and was on-site, hitting the sore spot – production.

Even though Deming has long been deceased, his ideas and (management) methods are more topical than ever before – especially where they have long been neglected: in the pharmaceutical industry.

The book entitled "The New Economics for Industry, Government, Education” revolutionised entire sectors 23 years ago. The pharmaceutical industry can only profit by it. The time is ripe for quality assurance that goes far beyond GMP. The FDA has also emphasized repeatedly that GMP conformity is considered to be a minimum standard. And who would claim to be satisfied with that in an environment of such rapid change?

Waiting for the digital game changer

In many sectors digital game changers are modifying the rules of the game and the behaviour of the people. Opportunities are often taken here that were previously overlooked. Amazon, AirBnb, Uber, Expedia, etc. have radically changed the particular sectors. When will the digital data of fitness bracelets, smartphones and other wearables be used to recognise and cure illnesses? In analytics alone it could be possible to achieve great progress. Perhaps you could spare 3 1/2 minutes of time for a video on YouTube: https://youtu.be/3X4v4VbhkrY

Now imagine patients being able to measure the ingredients of their medicaments with the aid of such devices.

Microsoft recently announced: Our goal is to find "a solution for the problem of cancer" within 10 years. Up to now, Microsoft has not been known for pharmaceutical solutions. Data and simulation with computers, however, take a completely different approach, and we shall be most interested in seeing where the journey takes us. It was repeatedly stated at the conference that the solutions to today's problems probably will not come solely from the traditional pharmaceutical industry. Who else will enter the stage?

And even if all of this is still situated within the realm of fantasy, the pharmaceutical industry should take advantage of new opportunities nonetheless. For what did Albert Einstein say 90 years ago:

"Imagination is more important than knowledge. For knowledge is limited, whereas imagination embraces the entire world, stimulating progress, giving birth to evolution." You could also say: “Fantasy is more important than knowledge, for the latter is limited!”

With this in mind, I wish you a lively imagination together with the knowledge born of experience and the unrelenting drive towards continuous improvement!



PDA/FDA Joint Regulatory Conference 2016, 12-14 October 2016, Washington DC


Thomas Peither
Executive Director and Editor in Chief
Maas & Peither AG, Schopfheim, Germany