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
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.
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
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?
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
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
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
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.
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.
Want to Learn More About Metrics?
Consider attending Session A3: “Quality Metrics,” Sept. 12, 10:45 a.m.–12:15 pm. at
the 2017 PDA/FDA Joint Regulatory Conference. Steven Mendivil, Senior Advisor, International Quality External Affairs at Amgen will be moderating this session.
Valerie Whelan, Amgen’s Vice President of Corporate Quality, will provide an industry
case study on using metrics to drive quality and prevent drug shortages. Her talk
will then be followed by the panel discussion on metrics featuring the following
representatives from industry: Barbara Allen, PhD, (Eli Lilly), Deborah Autor (Mylan), Harry Jeffreys (Catalent Pharma Solutions,) and Susan Schniepp (Regulatory
Compliance Associates). U.S. FDA representatives have been invited to speak as well.
Allen, Autor and Jeffreys, along with Guy Villax (Hovione), Carol Montandon (Johnson & Johnson Consumer), and Melissa Seymour (Biogen) offered their
opinions on the impact of FDA’s quality metrics on different segments of pharma
at the 2017 PDA Pharmaceutical Quality Metrics and Quality Culture Conferencein Bethesda, Md., Feb. 21. An excerpted transcript of their talking points was
published on the PDA Letter website.