Interview ISPE

First Europe Annual Conference Raises a flag for More Europe in the ISPE

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The key issue to be discussed at the conference is how to reconcile increased effectiveness with a quality culture? Where is the industry struggling at the moment?

Zimmer: Many international pharmaceutical companies are currently trying to manage quality problems. The audit authorities are more critical. Many deficiencies are being identified at the plants and as a result the plants are not GMP compliant. The work is not being carried out in accordance with the regulations as interpreted by the authorities.

The FDA in particular does not hesitate to take drastic measures. This can create shortages, and the population does not always have access to adequate supplies of drugs. The effects are felt by the segment of the pharmaceutical industry which conducts research as well as by generics manufacturers and OTC drug makers.

How does the conference intend to contribute to an improvement of the quality situation?

Zimmer: We have a clear message. Quality problems cannot be solved by the Quality Assurance Department alone. Everything is inter-related at a pharmaceutical plant. All of the functions which operate at the technical level including Production, Quality Assurance, Quality Control, Logistics and Engineering acting in unison must engage in an interdisciplinary dialogue and work to improve quality. Quality must be built into the process right from the start. It cannot be inspected in after the fact. We want to address all of the functions at the plants.

The Executive Forum on the first day and the keynote sessions on the following morning will be the conference highlights. What topics are on the agenda?

Zimmer: The Executive Forum and keynote speeches will zero in on the really big challenges in pharmaceutical production. They will be looking at market realization, supply chain integrity and how to prevent non-compliance from causing drug shortages. Experts from Mc Kinsey will be addressing the compliance-shortages issue based on their 10 years of experience with the Pobos database. This is a very important issue.

We need to understand how to resolve the apparent conflict between lean production and compliance. Keynote speaker Dr. Wolfram Carius from Sanofi Frankfurt will be sharing information on the challenges facing the biopharmaceutical industry. The talk by John Pinion from Roche will be another highlight. Roche currently has a reputation in the community for being highly innovative. It is seen as a company which has succeeded in completely revamping its Quality Assurance systems.

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