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GMP LOGFILE Features

2018-07-18

LOGFILE No. 27/2018 – Pharmaceutical Industry Highlights - Past, Present, Future

Pharmaceutical Industry Highlights - Past, Present, Future

A report on the PDA European Annual Meeting 2018 – Part 1

6 minutes reading time

by Thomas Peither

 

Outstanding! This is my one-word summary for the PDA European Annual Meeting 2018. In this first article you will read about the plenary session on Pharmaceutical Industry Highlights - Past, Present, Future, and get snapshots of topics presented on 26 and 27 June in Berlin.

This text (and many more) was also published in my live reporting from the conference on LinkedIn (#gmppublishing).

Future Opportunities and Directions for Pharmaceutical Manufacturing - A Global View

Axel Glatz from Pfizer started with a great presentation, giving his view of today’s pharma manufacturing. New technologies are knocking on our doors. Pfizer made the first experience with continuous manufacturing, NIR real-time release, Raman ID testing, lean manufacturing and connected tools.

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“The high volatility of manufacturing is critical!”

One of the big challenges is the high volatility of manufacturing. Analysing the volatility is crucial, critical and difficult. Alex Glatz gave great insight into the analysed data of this manufacturing site in Freiburg. And the problems do not end at the site. The shipping and transports between sites are critical, too.

The solution for Pfizer is the IMEx (Integrated Manufacturing Excellence) approach. The first experience was disappointing, but you have to learn from it.

These three pillars are the base for IMEx:

  • Operating system
  • Leadership system
  • Cultural system

Axel Glatz focused on the operating and leadership systems because cultural system and developments is a topic of its own.

“Isolated tools will never cure our systems!“

The Process-Centric Team is the key team in the operating system. It enables the people in manufacturing to improve processes. It develops standards for processes and visualises progress to the management board and the leadership cascade. The Process-Centric Team is the steering wheel for the process. It reports at shift change and communicates progress and the current state of the process.

A dedicated knowledge management is important to realise a sustainable system and to transfer knowledge to other sites. Leveraging knowledge is crucial for a global roll-out. You should be focused long-term to reach the goal - it is a long, challenging way to reach first goals.

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“You get so many questions, information and new views going this way of operational excellence!“ said Axel Glatz in his great start to the conference.

Reducing Complexity in Pharma

“Reducing Complexity in Pharma“ was the title of the second presentation on Tuesday, June 26, 2018. Marc Philipp, Accenture, focused on general financial figures of the pharmaceutical industry in a disappointing presentation. He showed some examples from customers: A ratio of 0.8 policies per employee was one of them, Marc Philipp stated. But is this a representative number?

“For every employee an SOP!?“

Ask yourself: What is your number in your company? Unfortunately, he focused only on big pharma but didn’t talk about small and mid-size companies.

Markus Hayek, also Accenture, focuses on simplification as a solution. He has vast experience in the automotive industry. “Avoid complexity the customer is not willing to pay for - manage necessary complexity rigorously”, he said. But in pharma, the customer is paying for other aspects than car buyers and the regulatory complexity is significantly higher and different from automotive. Nevertheless a good question was, “Is it necessary to increase complexity to introduce new colours or shapes of medicinal drugs?“

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But not a word about drug safety and efficacy, the regulatory framework and market authorisation challenges. A lot of buzzwords, less usable information. PDA had a good idea to bring the topic of simplification to the podium. But the performance could have been better. What a pity!

The Patient's Perspective: Past, Present & Future of Diagnosis and Therapy

“The worst thing is to have the control.“

This was not a quote on quality control, but a statement Jette Christensen made in her talk from the patient’s point of view. And the perspective of patients is important for our daily work. Jette Christensen, a well-known and very active PDA member, talked about herself as a patient.

She talked very openly about the chronic illnesses she is suffering from. It is important for all of us to see the patient at the centre of our profession. In the first line, it is not the profitability or the financial number that provides the motivation for us to go to work every day. No - to help patients to survive and enhance quality of life is the driver and the motivation for most of us.

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Jette talked about treatment progress in the last 50 years - and it was a fascinating journey from the sixties until today. From museum-ripe equipment to modern manufacturing.

The hardest thing about chronic diseases is “to have the control,“ she said. "I have to be aware all the time." Thank you so much for this great and touching talk - we should hear more about such patient stories.

 

LOGFILE-27-PDA-Annual-Europe-Part-1.docx.pdf

 

Links to the posts:

https://www.linkedin.com/feed/update/urn:li:activity:6417273834705035264

https://www.linkedin.com/feed/update/urn:li:activity:6417278003763507200

https://www.linkedin.com/feed/update/urn:li:activity:6417283537862434816

https://www.linkedin.com/feed/update/urn:li:activity:6417295686324219904

https://www.linkedin.com/feed/update/urn:li:activity:6417302172630806528

 

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Author:

Thomas Peither
Executive Editor
Maas & Peither AG - GMP Publishing
E-Mail: thomas.peither@gmp-publishing.com

Comments
Thank you Thomas for the candid reviews. I agree, it is good to look to other industries for input, but clearly, drugs aren\\\'t cars. I remember an early adoption of a manufacturing system from the automobile industry in chemical production. The system was adamant, a car has 5 tyres = 100%, not a bit more or less, like in chemical yields. The idea of using automated systems of course was a good one. Siegfried
Siegfried Schmitt 2018-07-18
 
 
 
Literature recommendation
GMP Compliance Adviser
Single User Licence (monthly subscription)
GMP Fundamentals – A Step-by-Step Guide (download)
Questionnaire for preparing GMP-inspections