Recent studies have shown that the total cost of compliance with internal quality systems and external regulations for a typical medium to large dosage form manufacturing facility is as high as 25% of the total site operating budget (exclusive of raw material costs) . For a medium-large production facility this amounts to €40 million per year. There is potential to reduce this element of cost by as much as 50%, but not by continuing with the current “cause no problems” attitude to manufacturing.
To reduce compliance costs, it is both necessary to understand the cost components in some detail, and to appreciate why they occur. It is also necessary to balance compliance costs against the incremental reduction to business risk that they deliver.
By understanding the nature of compliance-related risk, where it occurs, and how to manage it, significant improvement opportunities may be identified that systematically reduce gross risk and reduce the cost of managing residual risk.
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