Quality & Validation

This Common Quality Mistake is Also the Most Avoidable One

By Lizzie Evans on March, 28 2017

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Lizzie Evans

This common quality mistake is also the most avoidable one.pngEnsure Your Quality Infrastructure Is Built For Long-Term Success

Earlier this month, our Consulting Services team attended the 41st International Good Manufacturing Practices (GMP) Conference in Athens, GA. The primary focus was on Challenges in Quality in a Global Environment, with sessions on topics including Quality Metrics, Data Integrity, Combination Products, Biologics & Biosimilars, and GMP Inspection Trends and Results.

A hard-hitting theme throughout these presentations was that more often than not, organizations choose to cover recurring Quality issues with “Band-Aid” solutions in order to meet aggressive deadlines and stakeholder expectations, rather than building a thorough Quality infrastructure. This approach appears to cost less in the short-term, but the long-term impact of failing to invest early-on in Quality training and infrastructure can be devastating to a clinical program.

How do you know if your Quality infrastructure is built for long-term success? Invest time during the planning phase of your program and ask yourself these 3 questions.

  1. Does our Quality infrastructure use a risk-based approach?
    A risk-based approach encourages the identification and mitigation of inherent risks by implementing adequate policies and procedures that are proportional to those risks. Defining risks, then differentiating threats, vulnerabilities and impacts of those risks allows for the development of stronger risk-reduction strategies.

  2. Do we have a Quality Management System (QMS) in place? More importantly, is there overarching governance inclusive of all departments that allows for adaptability with new industry guidance?
    Your QMS should define policies, objectives, organizational structure, responsibilities and processes at a minimum. A strong QMS ensures that business operations are documented, repeatable, adaptable to industry change and focused on continuous improvement.

  3. Do we foster a foundation for Quality in our people, processes and technology?
    Regularly conducting training, mock inspections, and reviewing effectiveness of SOP’s leads to time and cost reductions and ultimately helps raise customer satisfaction. Giving your teams consistent, systematic methods to approach quality allows them to focus their energy on service while embedding quality in daily activities.

Ensuring your quality infrastructure is built for long-term success will save time, resources and reduce likelihood for increased FDA intervention.

Let us know what other strategies you use in planning your Quality infrastructure to avoid issues in the comments section below.

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