The pharmaceutical industry and its regulators are strongly focused on all quality issues because at the end of the day, drugs often make the difference between life and death. It is therefore crucial that patients can trust the producers of their medicine. The approach to quality management in the pharmaceutical industry is slowly starting to change. And the industry now sees the advantages that other industries have enjoyed for years of developing much more advanced and cost-effective quality techniques.
Although they seldom make headlines, the quality assurance tools and systems for edicines developed under the WHO Expert Committee on Specifications for Pharmaceutical Preparations help a broad spectrum of public health actors to meet that challenge and to work towards ensuring that all essential medicines, including those used in treating large populations, are safe, effective and of good quality.
For the pharmaceutical industry, Quality by Design is not only about adjusting to a new set of requirements - it is an opportunity to import modern quality management techniques and use them for more cost-effective manufacturing and quality management.
Across Europe, the USA and Japan, the pharmaceutical industry as well as regulators, agencies and organisations including WHO have agreed through the International Conference of Harmonisation (ICH) to follow the principles of Q8 (pharmaceutical development), Q9 (quality risk management) and Q10 (pharmaceutical quality systems).
They do so on the common understanding that this is a better way to control quality than using the traditional pharmaceutical quality methods. The principles of the ICH should be encouraged – and will perhaps become statutory in the future. European regulators accept both the traditional and the new approach, also called the ‘enhanced approach’. The US Food and Drug Administration (FDA) calls the new concept the ‘desired state’ and both Europe and the FDA promote the application of quality risk management methods, statistics and other scientific tools.
But whatever the subject, the aim remains the same: to promote production quality and better pharmaceuticals. For the sake of patients.
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To read more about QbD, read our Angle magazine on the topic.