The application of statistical process control in the pharmaceutical and biotechnology industries

A practical approach
Erscheinungsjahr 2014
ISBN: 978-1-907568-33-6
Verlag: Woodhead Publishing

Buch, Englisch, Band 28, 220 Seiten

Reihe: Woodhead Publishing Series in Biomedicine

The application of statistical process control in the pharmaceutical and biotechnology industries is a starting point for anyone interested in or who has been tasked with introducing these new pharma initiatives. It is a practical guide on how to apply statistical process control or SPC within the pharmaceutical industry. The book considers the various areas where SPC thinking can be applied and demonstrates the benefits that can be achieved by its use. It encourages all those involved in the industry - whether it be production, quality or the regulatory bodies - to start assessing data in a different way.

Autoren/Hrsg.

Cochrane, T

Fachgebiete

• Wirtschaftswissenschaften Betriebswirtschaft Wirtschaftsmathematik und -statistik
• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie
• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Spitzentechnologiesektor

Inhaltsverzeichnis

History of statistical process control; Why now in the pharmaceutical and biotech industry; Getting the culture right; The pharmaceutical industry; The system; SPC theory; Raw materials and supplier development; Key parameters; Auditing; Manufacturing processes; Training; Finished product testing; Critical quality attributes; Validation; Continuous verification; The annual product review; Putting all the information together; Reducing the risk in the system; Continuous improvement teams; Sales; Case studies.

Über Autor(innen)

Tom Cochrane has worked in the pharmaceutical industry for 30 years, holding positions of Quality Control Analyst, Quality Control Laboratory Manager and Quality Assurance manager. For the last 10 years he has worked as Business Process Development Manager with NAPP Pharmaceutical Group in Cambridge, UK, where he is tasked with embedding quality principles throughout business processes. Since 1995 he has been installing SPC thinking in many areas of the business He has been involved not only in the traditional areas of manufacturing and quality control but in other business functions such as sales, finance, drug development, regulatory affairs, human resource and supply chain security. The author is a strong advocate of the works of Deming and since 1995 has been an active member of the SPC User's Group.