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Pharmaceutical Manufacturing and Packing Sourcer

Validation and Management of the Project Development Process

Legal and regulatory issues continue to increase in stringency; for example, recent moves by the US Food and Drug Administration (FDA) against the threat of bioterrorism and the introduction of 21 CFR Part 11 compliance. Coupled with these considerations are increasing commercial pressures affecting pricing, product life cycles and the costly quest for new molecules. All of these factors have caused many pharmaceutical companies to rethink manufacturing policy, as well as their approach to project management and standardisation.

Therefore, pharmaceutical companies have never been under more demanding conditions than now, with the constrictions of legislation and rising investment requirements applying further pressures. As a result, most companies are having to consider very carefully how they develop and deliver new drug products.

A pre-eminent specialist in pharmaceutical plant design, Professor W J Lhoest (1) identified in a paper published in 2000 that rationalisation had to occur in the industry. He stated that: "rationalisation means a combination of efforts in multiple directions: simplification of manufacturing systems, a reduction of the production cycle time, a decrease in the number of different raw materials and also the number of commercial presentations, rationalisation of packaging formats, optimisation of batch sizes, a drastic simplification of the paperwork, elimination of staging, automation of material handling, and the clever but reasonable use of computers.


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By Karl Felgate, Schneider Global Business Development Team at Schneider Electric

Karl Felgate is International Account Manager within Schneider Electric's global business development team, where he specialises in the pharmaceutical industry. Karl has been working in this role for four years, managing both national and international accounts. He has been with Schneider Electric for 16 years and began his career in production project management for industry, with a primary bias towards automation. He quickly progressed to account management, where he developed his expertise in the pharmaceutical field.

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Karl Felgate
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17 September - 18 October 2008, Barcelona

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