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Pharmaceutical Manufacturing and Packing Sourcer
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The pharmaceutical industry has long been known for its conservatism and reluctance to embrace change. It is also an industry in which supply chain and manufacturing functions have traditionally been in the shadows of research and marketing. The major reason for such caution among pharmaceutical manufacturing executives is that the industry is heavily regulated.
Pharmaceutical manufacturers have become accustomed to operating to strict guidelines, following standard operating procedures and being liable at all times to regulatory inspections of production facilities at a moment's notice. Such an environment is not supportive of skills in the areas of creativity or innovative thinking! Instead, the focus is on closely following carefully defined and documented guidelines.
The regulators have the authority to shut down production facilities and even delay the approval for new products in cases of severe non-compliance. In the recent case of a postponed launch, a company lost an estimated US$500 million in sales because the FDA lost confidence in the company's ability to ensure adequate manufacturing controls. The company also lost what would have been between a six and 12-month period of market exclusivity for the new product.
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By Jim McKiernan, Partner at PricewaterhouseCoopers in Basel, Switzerland
Jim McKiernan graduated with Honours in Electrical Engineering from University College Dublin in 1980 and spent eight years in industry, before joining Coopers & Lybrand as a Consultant in 1988. During his time in industry, his work included the commissioning of production equipment worldwide, the management of a manufacturing facility in Cairo, Egypt and the implementation of manufacturing planning and control systems.
Since joining PricewaterhouseCoopers, Jim has applied his experience by assisting clients in supply chain management, manufacturing operation improvements, and in the application of
supporting processes and systems. For the past 10 years his work has been exclusively in the pharmaceutical industry, where he focused on many aspects of supply chain management and technology transfer between drug development and manufacturing. He has led a number of re-engineering projects in this area, helping companies develop responses to the technical challenges posed by ever-decreasing clinical development timelines. He also leads PwC's European Pharmaceutical Supply Chain Consultancy Service.
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