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Industry Expert Weighs in on Quality Metrics

Quality metrics remain a focal point of discussion within industry. In session “A3: Quality Metrics” (Sept. 12, 10:45 a.m.) at the 2017 PDA/FDA Joint Regulatory Conference, there will be a panel discussion on quality metrics featuring industry leaders. One of the panelists, Susan Schniepp, Distinguished Fellow, Regulatory Compliance Associates, offered her views on quality metrics for the PDA Letter.

PDA Letter: It’s been just over four years since Janet Woodcock issued her call for quality metrics and the first PDA conference on the topic. What has industry learned over the past four years?

Schniepp: I think we have learned that quality metrics are complicated, and that reliability of these metrics is dependent upon an organization’s quality culture. And quality culture is a very aspect of metrics.

We have to also realize that companies are already collecting metrics and, in many cases, they are collecting the metrics specifically asked for by the U.S. FDA.

Quality Metrics

PDA Letter: How does quality culture relate to metrics?

Schniepp:The culture of an organization relates directly to the reliability of the metrics being reported. When there is a functioning quality culture, the information can be assumed to be reliable and accurate. When a good quality culture is not forthcoming, then there could be issues with the metrics. Some of the metrics may be suspect because a poor culture will drive undesired behavior and that might result in inaccurate metrics where not all the information is reported.

PDA Letter: What are industry’s main concerns about the FDA’s quality metrics program at this point?

Schniepp: The main concerns I’ve heard seem to be the amount of time and man- hours needed to gather, review and submit the information to the Agency. And the larger, unanswered question is how the Agency intends to use the information once it has been submitted by a company.

PDA Letter: What has changed with regard to metrics since the first PDA metrics conference in 2013?

Schniepp: Since PDA’s 2013 metrics conference, the FDA guideline has been issued twice along with a technical guideline. I think the Agency is also now looking at this to be a voluntary program instead of mandatory. Industry is still not that accepting of the program, so that is one aspect that has remained the same. The requirements for reporting have changed and it seems, with the last version of the guideline, that reporting will be voluntary.

PDA Letter: For a small company that is starting out on the quality metrics journey, what three things should the organization consider?

Schniepp: First, establish a positive culture. Second, establish meaningful metrics that drive continuous change. And three, establish goals that measure product quality. These should be realistic and constructed so they do not drive undesirable behavior.

PDA Letter: The FDA has added a voluntary reporting phase of the quality metrics program, and there has been additional industry feedback after the most recent revised FDA draft guidance. What would you recommend companies do today in regards to the metrics program?

Schniepp: I think companies should be receptive to the metrics program and accept it for what it is trying to accomplish. The point of the program is to monitor and correct potential issues before there is a drug shortage. Companies should review their data and see if they can’t do some self-correcting before there is a drug shortage. And companies should not be afraid to work with the Agency to solve problems in their quality systems or manufacturing systems before they result in drug shortages.

PDA Letter: Could a company tie the FDA’s metrics in with their overall metrics, ensuring the process is scaleable as more metrics are expected to be reported? Or should another approach be taken?

Schniepp: I think it would be advantageous for a company to tie their metrics to the FDA program, but I would not limit the metrics to only those called for in the guideline. The metrics specified in the guideline are lagging metrics. It would be wise for companies to establish leading metrics so they can react faster to problems.

PDA Letter: What are PDA’s next steps when it comes to quality metrics and quality culture?

Schniepp: We are still working on a quality culture tool because we feel that this is an important part in making the metrics meaningful for both the company and the Agency.

About the Expert

Susan SchnieppSusan Schniepp is a Distinguished Fellow at Regulatory Compliance Associates. As an active member of PDA, she is on the Board of Directors and has been a member of the planning committee behind the PDA/FDA Joint Regulatory Conference since 2001.


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