Falling investment into pharmaceutical manufacturing risks non-compliance with regulations

The high level of pharmaceutical company mergers and acquisitions plus industry-wide cost cutting has squeezed investment into manufacturing, but companies must be careful as failure to invest properly may lead to non-compliance with the appropriate Good Manufacturing Practice (GMP) regulations, warns a new report from Urch Publishing.

The effect on the stock value and image of the company of not getting it right has been amply demonstrated in recent years. The level of fines being levied by the Food and Drug Administration in consent decrees makes it financially painful for companies that fail to comply to standards, according to the report Manufacturing in the Global Pharmaceuticals Industry - Key drivers, company strategies and regulations.

One thing is clear", says report author, Dr Kate McComick, the days of the pharmaceutical company being manufacturing--driven are over. Many companies do not see manufacturing as a core competency, but rather consider it merely as an activity that must be carried out efficiently and effectively for the company to perform. However, they must be careful and abide by the rules or risk being penalised by the authorities".

It is important that investment in manufacturing is recognised as just that -- an investment -- rather than an expense that brings no returns. The question - Why should we invest this money? - should be balanced by an understanding of the implications of not making that investment", says Dr McCormick, a consultant, who has over 20 years experience in pharmaceutical manufacturing.

The report provides an overview of pharmaceutical manufacturing and serves as a reference text for companies that are introducing international standards of quality in manufacturing. It also reviews the main dosage forms being produced and the related technologies, merits of Greenfield project versus refurbishment and validation.

Manufacturing in the Global Pharmaceuticals Industry - Key market drivers, company strategies and regulations is 100 pages and contains over 35 figures and tables. It is priced at 850.

Urch Publishing is an independent business information publisher dedicated to delivering high quality information products to the global pharmaceuticals industry. Further information about the report, including full table of contents can be found at www.pharmaceutical-manufacturing.com.

For more information contact Urch on +44 (0) 208 690 8780
or email: service@urchpublishing.com
Urch Publishing, PO Box 27554, London SE4 2GZ, United Kingdom