Achieving operational excellence is a challenge for the pharmaceutical industry, with many companies setting successful examples time and again. This book presents such leading practices for managing operational excellence throughout the pharmaceutical industry. Based on the St.Gallen OPEX Model the authors describe the current status of OPEX and the future challenges that have to be dealt with. The ample theoretical background is complemented hand-in-hand by case studies contributed by authors from leading pharmaceutical companies.​

Launching Operational Excellence (OPEX) constitutes a true challenge for every manufacturing organization. Changing the habits and behavior of people, making them to leave the beaten track and ultimately changing their mindset to continuous improvement is a real management task and demands leaders to be charismatic, encouraging and tenacious. This especially holds true for the highly regulated pharmaceutical industry and its heritage of reluctance to change. Nevertheless, most large pharmaceutical organizations based in advanced economies have launched an OPEX program in an effort to holistically improve their operations since the turn of the millennium. Moreover, after the first results and realized benefits have been publicized, the transformational concept found its way to small and medium-sized pharmaceutical manufactures and did not stop to enter domestic organizations of the so called emerging markets. These markets distinguish substantially from advanced economies and their unique setup make it nearly impossible, to transfer the concepts that work perfectly in western organizations to domestic emerging market manufacturers without any localized adaptions. This dissertation suggests an approach how domestic pharmaceutical manufacturers in emerging markets can design their individual OPEX program that fits to their specific internal and external requirements. First, two literature reviews examine the knowledge base on emerging markets and OPEX. These reviews provide deep insights into what constitutes an emerging market and list the major influences of these markets towards domestic manufacturing sites. Furthermore, the philosophy and elements of OPEX are analyzed and critically reflected within a pharmaceutical and emerging market context. Second, a benchmarking of OPEX practices of 267 pharmaceutical manufacturing sites allows the comparison of sites in advanced and emerging markets. Subsequent case studies and workshop.

In dem Buch werden die Ergebnisse einer Benchmark-Studie zum Thema "Operational Excellence in der Pharmaindustrie", die von der Universität St. Gallen und der Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e. V. (APV) durchgeführt wurde, zusammengefaßt und ausgewertet. Über 100 Pharma-Produktionsstätten in mehr als 20 europäischen Ländern wurden im Rahmen der Studie hinsichtlich des Ist-Zustandes ihrer Produktionsperformance unter besonderer Berücksichtigung der Anforderungen des "Lean Managements" untersucht. Die Autoren geben eine detaillierte Übersicht über die Studienergebnisse und präsentieren einen umfangreichen Maßnahmenkatalog, mit dessen Hilfe eine Steigerung der Operational Excellence von Pharma-Produktionsanlagen erreicht werden kann. Die Ergebnisse von sieben beispielhaften Fallstudien, die besonders umfangreich analysiert wurden, sowie ein Ausblick auf die wesentlichen sich bereits abzeichnenden technologischen Weiterentwicklungen im Bereich Pharma-Produktion vermitteln dem Leser praxisnahes und hilfreiches Wissen, um Verbesserungspotentiale im eigenen betrieblichem Umfeld analysieren und umsetzen zu können. Führende Pharma-Experten aus den Bereichen Management sowie Forschung & Entwicklung haben dazu beigetragen, das Thema Operational Excellence erstmals aus Sicht der Pharmaindustrie umfassend zu behandeln. Zielgruppen:- Pharmazeutische Industrie- Auftragshersteller- Zulieferindustrie- Anlagenbau- Planungsunternehmen- Consulting-Unternehmen- Universitäten und Fachhochschulen- Behörden (Überwachungsämter).

Discover new strategies for maximizing performance and profit across your organization through the concept of operational excellence. Companies must learn that you cannot fire and budget-slice your way to sustainable growth. Our world is too complex, too interconnected, and technology too quick-evolving for organizations to achieve dramatic results simply by eliminating waste and increasing standardization. Maybe these methods worked before--occasionally--but not anymore. Redefining Operational Excellence boldly claims that the old ways of hunkering down and refocusing the business strategies are no longer viable. Operational excellence is about a mindset, and a company culture that questions current models and focuses not on slashing and subtracting but on adding value, making improvements, and increasing speed. This groundbreaking guide covers it all--processes, people, and operations--and shares specific strategies to: Drive innovation and collaboration Engage customers Attract and retain top people Align strategy and execution Optimize speed Operational excellence is about finding money and performance boosts in hidden areas businesses don't normally look. With this indispensable, all-encompassing resource, you’ll discover where!

Neue Technologien, sich wandelnde Geschäftsstrategien, Kostendruck auf Hersteller und Zulieferer, migrierende globale Wertschöpfungsketten sowie neue regulatorische Anforderungen sind die Herausforderungen der Pharmaindustrie. Um in allen Bereichen Exzellenz zu erreichen gilt es, den Fokus auf die Menschen zu richten. Sie planen, bewirken, verbessern und erfinden neue Strategien, erfahren, Systeme und Strukturen. Die Fähigkeit zur Überwindung der inneren Trägheit eines Unternehmens macht den Unterschied. Die höchsten FundE-Ausgaben verzeichneten die Unternehmen, die sich nicht weiter mit einem eingeführten und evaluierten Verfahren beschäftigten. Das beeinträchtigte Innovationen im Produkt- und Substanzbereich. Veränderungen werden an Geschwindigkeit und Umfang zunehmen. Hier setzt die Operational Excellence ein. Dies impliziert, das Herstellungspotenzial zu entwickeln, als Grundlage einzigartiger Geschäftsstrategien. Dazu erforderlich sind Exzellenz in Führung und Management, Methoden und Tools sowie Technologie und Innovation. Zielgruppen:- Pharmazeutische Industrie- Zulieferindustrie- Fachhochschulen / Universitäten- Beratungsunternehmen- Behörden.

This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also provides good practice examples of how the effective use of an organisation’s knowledge assets can provide a path towards business excellence.

Bikash Chatterjee emphasizes the criticality of applying the principles of Lean and Six Sigma within the paradigm of the drug development process. His guide to operational excellence in the pharmaceutical and biotech industries is a focused summary of the application of Lean Six Sigma theory to the regulated life sciences. From molecule discovery to the application of PAT Applying Lean Six Sigma in the Pharmaceutical Industry will highlight the importance of framing these initiatives within the key deliverables of drug development manufacturing and quality. Challenging conventional wisdom the author offers a quality and efficiency perspective as a foundation for the principles of Quality by Design, PAT and the new philosophies underlying Process Validation. Each chapter includes discussion around the considerations for applying Lean manufacturing and Six Sigma principles and their tools, culminating in a case study to illustrate the application. The book is organized to reflect the major work centers involved in the drug development lifecycle. Each chapter is stand-alone but together they illustrate the necessary synergy between Lean, Six Sigma and compliance sensibilities required to be successful in the pharmaceutical industry. These design, manufacturing and management techniques are not without their challenges. Bikash Chatterjee's book offers the roadmap for an industry that is struggling to reinvent many of its development and business processes.