Quality by Design

The successful implementation of a modern Quality Management System (QMS) based on QbD and Quality Risk Management (QRM) does not depend on the choice of the right methodology or tool kit but on a paradigm change initiated by top management.


QbD is not a short-term measure to realise short-term cost savings, but to be successful, requires long-term commitment by staff at all levels. If the process is applied consistently and in a disciplined manner, operational excellence is the result. The International Conference on Harmonisation (ICH) started implementing QbD (i.e. ICH Q8, Q9 & Q10 guidelines) in the Good Manufacturing Practice (GMP) area, but the introduction of QbD principles and methodologies into the clinical and pharmacovigilance areas is still in its infancy.


QbD builds quality into a process rather than ensuring quality of a product or service through audits and inspections. QbD requires that inputs and outputs as well as interdependencies between successive process steps are well understood and documented, design criteria with clear deliverables for each step are defined, and demands for clear and unequivocal ownership of each design element or process element is established. To avoid QbD being mistaken for a bureaucratic approach, the active contribution of technical experts and process owners at multiple levels is essential so that documentation and controls are kept to the minimum yet ensures a quality product or service.


How can Widler & Schiemann assist you with your QbD projects?
Both partners (Dr. B. Widler and Dr. P. Schiemann) have an extensive track record in setting up and implementing a QbD approach in the clinical trial and pharmacovigilance areas. They defined and successfully implemented the concept in the clinical development and medical affairs functions while working at their previous companies. They are considered thought leaders in QbD and QRM by their peers and they both have an active role in the Clinical Trial Transformation Initiative (CTTI) project led by US FDA and Duke University. They are regularly invited to speak at international conferences and are sought as instructors in this field.

Widler & Schiemann will work with your experts and process owners to define a strategy to introduce QbD into your organisation, support the definition of a change management plan and support roll-out and implementation. Once QbD has been deployed, Widler & Schiemann are available to support your organisation in maintaining a fit for purpose QbD process by sharing insight gained through their work in public – private partnerships. Your organisation will benefit from industry best practices and alerts about pitfalls observed elsewhere.

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