A highly diversified pharmaceutical company based outside Europe has grown by acquisition and has developed a range of quality management systems (QMS) and inherited a number of others. It consisted of a number of sites managed directly by the organisation and nearly 50 subsidiaries that were managing the sale of major products.
These subsidiaries often used local contractors to manufacture other products for the local market only. Furthermore, the company strategy was to increasingly outsource more of its activities with only a very few sites managed directly by the company.
At the time of this project, there were nearly 300 external organisations across the company, directly involved in the development, manufacture, testing an distribution of the company’s products.
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