iSpeak Blog

New Quality Culture Drives the Comeback of Pharmaceutical Engineering


The pharmaceutical industry is facing a restructuring in quality management.  The manufacturing goal of producing consistent, high-quality products with minimal regulatory oversight is revealing a new path. The FDA and CDER are in the process of restructuring with the proposed Office of Pharmaceutical Quality and the European Medicines Agency (EMA) continues to update chapters and annexes of the EC GMP Guide in order to prevent cross contamination or ensure end-to-end supply chain integrity.

All of these changes will have an impact on manufacturing processes, material flow, and factory layouts as well as on quality systems design and quality risk management. Furthermore, the issue of drug shortages leads to an alignment between the FDA and EMA requiring consolidated industry feedback about root causes, mitigation prevention, and regulatory interaction. “The impact on quality systems and on quality culture will be significant", according to Dr. Thomas Zimmer, ISPE’s VP of ISPE European Operations, "it is up to industry stakeholders to prepare, educate, and discuss the new conceptual framework of manufacturing.” Adopting a Quality Culture philosophy involves the entire pharmaceutical network.

There must be a total commitment to invest and embrace the change toward the desired state of continual quality.  Mutual learning, sharing knowledge, and analyzing “root causes” are essential parts of adopting a culture of quality. ISPE acknowledges their part in quality culture by bringing together industry professionals to share recent knowledge and discuss the implementation and importance of proactive quality management.  ISPE’s new Europe Annual Conference will take place on 28 – 30 April 2014, addressing this modernization of quality manufacturing. 

The Sheraton Frankfurt Airport Hotel and Conference Centre in Frankfurt, Germany will host the inaugural conference themed “Driving Effectiveness in Pharmaceutical Operations with the new Quality Culture.” Pharmaceutical, regulatory, and technology experts from around the world will explore current operational challenges and quality systems effectiveness, including current regulatory trends.  Industry opportunities, such as Quality by Design (QbD), science-and risk-based approaches, and continuous manufacturing also will be discussed. According to Zimmer, “Our goal is to provide an annual event that meets an international need to discuss, collaborate, and align industry perspectives on key pharmaceutical manufacturing topics. ISPE created this conference to support European stakeholders with their efforts to develop and apply the latest technologies in manufacturing high quality pharmaceuticals.” The 2014 Europe Conference will include an executive session, plenary session, and multiple focus tracks to meet various educational needs. Learn more about the conference here.