Implementing QbD Initiatives

Peter Boogaard

Continual improvement drives quality and starts at the top

Leadership, outstanding processes, and culture are the ingredients for making companies successful. When Philip Crosby published his first business book in 1979, Quality Is Free, and initiated the principle of "doing it right the first time", the Q word was born. Today the Q word is a given and here to stay. But what is Quality? How do you measure Quality? Is Quality related to a product, a process or a system or all above?  The Quality Transformation is a culture of commitment to continual improvement.

The approach towards defects should be one of avoidance, prevention and resolution. The aim should be to do things right the first time anyplace, anywhere and anytime in the product quality lifecycle implementation.  We all can have all SOP’s, systems and controls in place, but without a quality company culture, product quality and business continuity is not assured. Great words, fantastic ideas, but the Q question is how to make it happen? How to enforce organizations to make it happen? Like always, the answer is simple. To make things happen, we need leadership.

Leadership starts from the top. For leaders to operate successfully, they will need solid, risk avoiding and robust guidance. Organizations such as ISPE, the world's largest not-for-profit association dedicated to educating and advancing pharmaceutical manufacturing professionals and ICH, a joint global initiative involving both regulators and research-based industry representatives, have been significant contributors to help the industry. The ICH Q10 guidelines provide clear and practical guidelines for senior management to transform quality values and embed quality improvement values to create a culture of continual improvement within the entire organization.

The other Qacronym QbD (Quality by Design) has come relatively late to the pharmaceutical industry. For years, other industries including the automobile, aviation and food & beverage have adopted, very successfully, the six sigma philosophy. What about integration of meaningful metrics such as Cost of Poor Quality (CoPQ) and how it substantiates of adopting the QbD mindset and culture? What brings QbD me anyway? I invite you to share your concerns, experiences and ideas. To be continued….

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