This item is in: Biomedicine > Manufacturing and processing

The application of statistical process control in the pharmaceutical and biotechnology industries: A practical approach

T Cochrane, Napp Pharmaceutical Group, UK

Woodhead Publishing Series in Biomedicine No. 28

 - the first book to describe SPC in the pharmaceutical and biotechnology industries
 - highly practical approach
 - contains many case studies showing the application of SPC
 - covers guidelines such as ICH Q10 and FDA's draft validation starting to mention understanding variability, but not telling you how to do it
 - is very timely - with pharma and biotech in a state of change, with more emphasis on reducing waste

The pharmaceutical industry is currently at a critical stage of its development. It is in an environment where big blockbusters for huge markets are a thing of the past, there is pressure from governments to reduce the drug costs, and stiff competition from generic companies as patents come to an end are all pushing the industry towards greater efficiency.

Supply chains have become lengthy and complex as many manufacturers either source from or move sites to Asia; this complexity has increased the risk of counterfeit, sub potent or harmful materials entering the legitimate supply chain. We have already seen cases where fatalities have occurred due to this.

The pharmaceutical industry can no longer afford the levels of waste it currently has and once upon a time could sustain.

Regulatory authorities have introduced initiatives that encourage companies to investigate and get an understanding of their processes to improve and control. Innovative new technology now allows the measurement and collection of data throughout many manufacturing processes previously unavailable.

This book is a starting point for anyone interested or has been tasked to introduce 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.

Although the word statistical appears in the title this is not a book on statistics; however, it does deliver a way of viewing data that is both simple and easy to understand and relates to our understanding of the world in which we work.

ISBN 1 907568 33 6
ISBN-13: 978 1 907568 33 6
September 2014
220 pages  234 x 156mm  hardback  
Approx. £120.00 / US$205.00 / €145.00

Not yet published

An e-book version of this title will be available from Woodhead Publishing Online. To view the current titles available visit Woodhead Publishing Online

About the author

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.

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21st Century quality management and good management practices
Ultrafiltration for bioprocessing
CAPA in the pharmaceutical and biotech industries

Contents

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.