Surely there is no industry where quality is seen as more important than it is in Life Sciences. Indeed, hundreds of thousands of people are employed by regulatory authorities to enforce quality through compliance to regulations, with an increasing appetite to exact heavy penalties from those that do not comply. Yet it is possible to argue that, despite all their efforts, the regulators are failing to meet their goal. Pharmaceutical companies have to focus so much on regulatory compliance that it sometimes seems that they might not be grasping the true meaning of quality.
Customers, however, are not so easily distracted. Educated, with easy access to up-to-date knowledge, they treat medications much as they do any other consumer goods. Brand strength and recognition are increasingly important, especially now that generic competition to off-patent medication is increasing. Global media and information exchange provides marketing opportunities, but also puts the company's brand at significant risk in case of failures. Needless to say, the potential legal consequences of massive law suites caused by adverse events or quality defects remain a constant threat.
Compliance alone just isn't good enough anymore. There are recent examples that demonstrate that significant failures in Quality Systems and Oversight do occur, even in companies that have been at the forefront of defining regulatory compliance. Quality is not just about satisfying regulatory requirements, but meeting the requirements of all stakeholders, including customers and shareholders. Ironically, Quality Standards that facilitate this have been around for decades and are well established in other, less regulated industries. For example, the ISO 9000 family of standards was set in 1987, but its foundation dates even further back to the British Standards of 1979. Its first certification was awarded to a company within the highly competitive road construction business, not an organisation operating in a highly regulated environment at all!
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