Over the last decade the pharmaceutical industry has changed dramatically. The need to continue to reduce costs has resulted in the outsourcing of manufacturing, and increasingly complex supply chains. Globalisation has become a feature of the industry. The FDA reported that in the USA the number of foreign drug products and manufacturing sites doubled over the course of six years; involving many imports from countries with less developed regulatory systems. Between 2001 and 2007 the number of manufacturers in India increased by a factor of twenty five, and in China by a factor of seven.
The main challenge associated with the change is that functional organisations of pharmaceutical companies are simply not designed to deal with this degree of complexity. Supply Chains now run through too many different parts of the organisation, without having clear ownership established, or shared objectives for the overall process. Certain issues are not picked up because they fall between departments, increasing both the overall problem and the risk.
One direct result has been the increase in product recalls; up a staggering 400% between 2008 and 2009. Furthermore, ingredient adulteration has become a serious problem. Everyone in the industry is familiar with the recent cases of OSCS contamination in Heparin and the recurring contamination of Diethylene Glycol in Glycerin.
Due to the complexity, most companies struggle to gain full oversight of the supply chain. Given this lack of oversight, what level of confidence can a company truly have when releasing the end product to market? Are quality agreements in place with all suppliers? Are all suppliers regularly audited? Even if agreements are in place, it is unlikely that all the required information is available at the point of release.
To view the article in full, please click on the pdf link below: