Incorporating QbD into the Provider Qualification Process

Posted in Process Improvement

Quality is a primary consideration in the design, planning, conduct, analysis, and reporting of clinical studies and a necessary component of clinical development programs. [ICH E8 (R1)]. Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control and is based on sound science and quality risk management.

Incorporating Quality by Design (QbD) leading practices into the Provider Qualification process is extremely important to proactively drive greater efficiency and risk management as well as continuous improvement. However, there are several challenges to overcome when implementing QbD leading practices. Many of the challenges can be anticipated and proactively addressed with a well thought out and planned approach. For example, the amount of information available to us now can help identify Provider experience and expertise and measure potential risks with Providers; however, the abundance of such can be daunting. More isn’t always better. Therefore, identifying elements that are most important to your clinical trials and those which have the greatest potential impact for improving quality in your Provider Qualification process are crucial to effectively incorporating QbD.

QbD practices should be woven into the Provider Selection and Qualification process in the simplest and most impactful way. It is important to keep in mind that easily incorporated and easily evaluated measures will be the most beneficial to your organization. 

Traditionally, Provider Qualifications have been carried out through a risk assessment process, but QbD measures have not always been incorporated into the process, and neither has evaluating a Provider organization’s success and experience in incorporating QbD practices into their own services. To move from a traditional Provider risk assessment to a more risk-based QbD approach, companies must adopt a Provider risk assessment process which incorporates not only review of traditional Provider capabilities, but also evaluates the Provider’s adoption and experience with QbD and risk-based quality management practices. This can be achieved by thoughtful planning in advance and by implementing questions that are targeted.

The following table provides some example questions that align with several of the risk-based categories set forth by ICH E6 (R2):

Risk-Based Categories set forth by ICH E6 (R2)Potential question for assessing a Provider’s experience with incorporating QbD
Risk identificationsHow are risks identified and measured, and how is this information disseminated across all stakeholders?
Risk evaluationAre case studies or application of concepts being presented?
Risk controlWhat plans are in place to mitigate risk, including business continuity, disaster recovery, etc.?
Risk communicationAre QbD concepts in contracting and governance being accepted/proposed by the Provider?
Risk reviewAre statistical tests or analyses being run across study data and/or services designed to identify atypical patterns and/or issues?
Risk reportingHow are risks being reported? Is there a well-defined plan for communication of risks and at the proper time intervals?

Identifying potential risks by asking questions which address what could go wrong, why or how that could go wrong, what the consequences are if failure occurs, and what mitigation steps can be implemented in advance to avoid the failure or to address the potential risk before it becomes an issue, will help build quality into your assessment process. (AQC Members can access Process Tool 04h – QbD Leading Practices When Outsourcing in the Knowledge Center.)

In addition, evaluating each risk by assigning a severity rating, a rating for the likelihood of occurrence and the detectability of the failure will also help improve the quality of your Provider assessments. (AQC Members can access PQUAL 01b – Core Scorecard Template in the Knowledge Center.)

Incorporating QbD and risk-based methodologies into Provider Qualification is no small task but the benefits are multifold, QbD:

  • Ensures your organization is compliant with current regulatory expectations
  • Improves collaboration with Providers
  • Identifies potential risks early in the process so they can be mitigated before they become issues
  • Helps Providers identify and address potentially unknown risks and plan for future improvements
  • Reduces redundancies through use of standardized and consistent templates and risk scoring tools
  • Helps to shorten study timelines by reducing the number of unexpected issues

It is important to keep in mind that regulatory authorities continue to emphasize and encourage the use of QbD and risk-based approaches in the qualification and oversight of clinical service Providers, as an industry, adoption of these methodologies across our clinical trials is expected.

By implementing these practices into your qualification and oversight processes you will gain operational success, higher quality trials, shorter timelines, and greater efficiency across your organization.

Members of the WCG Avoca Quality Consortium (AQC) have access to leading practice documents and metrics that can help you utilize the described approach. These tools are among a total of over 500 leading practice documents and 1,000 metrics assets in the AQC Knowledge Center.

Learn more about becoming a Member of the AQC and/or how our consulting services can help your company implement QbD processes into your Provider Qualification and Oversight Practices.
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