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2013 | OriginalPaper | Chapter

3. The History of OPEX in the Pharmaceutical Industry

Authors : Thomas Friedli, Jürgen Werani

Published in: Leading Pharmaceutical Operational Excellence

Publisher: Springer Berlin Heidelberg

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Abstract

The History of Operational Excellence in the Pharmaceutical Industry is still short. Serious initiatives were only launched around 10 years ago. This chapter provides some background on how and why OPEX became a topic of serious interest in this industry.

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previous chapter OPEX: A Definition

next chapter The Current State of Operational Excellence Implementation: 10 Years of Benchmarking

FDA, Final Report “Pharmaceutical CGMPs for the 21st Century – A Risk-Based Approach”, September 2004.

Guidance for Industry PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, FDA, September 2004, Page 3.

Janet Woodcock (2011).

Bruttin and Dean (2004).

Cf. Report of the PAT Team and Manufacturing Science Working Group 2004, Page 1.

Cf. Clark (2004): FDA’s PAT initiative, in: Pharmaceutical Technology Europe.

Clark (2004).

Cf. Report of the PAT Team and Manufacturing Science Working Group 2004.

FDA 2004b.

Bruttin F, Dean D (2004) Managing the cost of compliance in pharmaceutical operations. http://www.efcg.cefic.org/fdxdownload_13.iK23abe1ee02e8be1e/publication_file/managing-the-cost-of-compliance-in-pharmaceutical-operations.pdf. Retrieved 22 January 2013

Clark G (2004) FDA’s PAT initiative, in: pharmaceutical technology Europe. http://www.pharmtech.com/pharmtech/Analytical/article/detail/129539. Retrieved 20 January 2013

FDA (2004a) Challenge and opportunity on the critical path to new medical products. www.fda.gov. Retrieved January 2010

FDA (2004b) Final report “pharmaceutical CGMPs for the 21st century – a risk-based approach”, September 2004. www.fda.gov. Retrieved January 2010

Gronauer T, Friedli T, Götzfried M (2010) The roadmap to operational excellence – pattern and elements of OPEX programs. In: Friedli et al. (2010) The pathway to operational excellence – overcoming the internal inertia. Editio Cantor Verlag, Aulendorf

Kickuth M, Friedli T (2006) The pharmaceutical plant of the future. In: Friedli T, Kickuth M, Stieneker F, Thaler P, Werani J (eds) Operational excellence in the pharmaceutical industry. ECV – Ed.-Cantor-Verl, Aulendorf

Report of the PAT Team and Manufacturing Science Working Group (2004) Innovation and continuous improvement in pharmaceutical manufacturing – pharmaceutical CGMPs for the 21st century. www.fda.gov. Retrieved January 2010

Woodcock J (2011) Presentation, meeting of the FDA science board, November 16th, FDA, Regulation of drug quality: new challenges. www.fda.gov. Retrieved 20 January 2013

Title: The History of OPEX in the Pharmaceutical Industry
Authors: Thomas Friedli
Jürgen Werani
Publisher: Springer Berlin Heidelberg
Book: Leading Pharmaceutical Operational Excellence
Print ISBN: 978-3-642-35160-0

Electronic ISBN: 978-3-642-35161-7

Copyright Year: 2013
DOI: https://doi.org/10.1007/978-3-642-35161-7_3