In February of 2022, the efforts of Xavier Health were assumed by the AFDO/RAPS Healthcare Products Collaborative. Because of the important work done before this transition, the Collaborative has chosen to retain documents that have Xavier branding and continue to provide them to the communities through this website. If you have questions, please contact us at info@healthcareproducts.org.
Predictive Product Quality and Business Continuity System
Xavier and PwC asked a select group of industry thought-leaders:
If you walked into a company today, what would you need to see in action to know that company has a strong commitment to quality?
Find out how to quantitatively measure the strength of your organization’s commitment to quality using the sophisticated algorithms in the SchellingPoint Alignment Optimization virtual interview process:
Contact us today to learn how this measure of quality commitment is incorporated into the Xavier/Schellingpoint Predictive Product Quality and Business Continuity System. Your organization could have a focused and specific action plan that will make a measurable difference in a matter of minutes. Imagine using the power of this assessment to quantitate the alignment across your organization, as well as between your organization and your supplier, or contract partner, or newly acquired/merged business operation–and then have in your hands a focused gap analysis and action plan!
Xavier Health Comments on the FDA Metrics Guidance
Independent of, and separate from, the Xavier/PwC Pharma Metrics Initiative, Xavier Health provided comments on the FDA “Request for Quality Metrics” Draft Guidance for Industry (FDA-2015-D-2537).
All comments provided to FDA for FDA Metrics Guidance can be found on the Regulations.gov website.
Excerpt from the eight-page Xavier Health comments:
I firmly support the use of risk-based decisions across the Agency and industry to identify how best to use available resources to protect and promote patient safety in a way that is commensurate with the need. Additionally, I fully support the intended multi-faceted purpose of this draft guidance to: (1) guide risk-based resource allocation decisions within the Agency, (2) improve the Agency’s ability to predict drug shortage circumstances, and (3) encourage the implementation of state-of-the-art innovative quality management systems across the pharmaceutical industry. Therefore, my comments do not question the merit of that intended purpose.
However, I do not believe that the proposed call-for-data approach will achieve the intended multi-faceted purpose of the draft guidance, and even more concerning will divert Agency and industry resources from activities critical to promoting and protecting patient health.
The Xavier University/PwC Pharmaceutical Metrics Initiative (2014-2015)
The Food and Drug Administration Safety and Innovation Act (FDASIA)[1] of 2012 gave FDA authority to request data and information from the industry in advance of or in lieu of an inspection to identify potential risk for drug supply disruption, improve the efficiency and effectiveness of establishment inspections, and improve FDA’s evaluation of drug manufacturing and control operations. This authority allows FDA to develop a process for resource allocation based on operations of greatest risk. As a result, FDA announced its Quality Metrics Initiative in February 2013 to ascertain data the industry could submit to FDA that would provide an indication of risk to product quality. FDA worked with the industry throughout 2013-2015 to identify metrics it could request from drug firms under its authority and issued its proposal in the “Request for Metrics” draft guidance.[2] Reviewing company-specific data out of context, however, could lead to false conclusions. In contrast, reviewing this data during an inspection could provide critical contextual information as it relates to the company itself, facilities, products, and importantly, risk to patients.
In support of FDA’s intent to allocate its resources based on risk, Xavier University and PwC launched a Metrics Initiative in August 2014 to identify product quality risk metrics linked to patient safety that could be viewed during an inspection. Xavier University and PwC led a team of 30 industry professionals that developed a framework of 11 metrics across the Total Product Life Cycle (TPLC). The proposed framework is designed for use by FDA and the industry to inform decisions and trigger action. It is built upon driving a mindset of continuous improvement that includes feedback loops across the entire enterprise to design quality in product proactively at the source, instead of reactively catching bad quality after manufacture. The team recommends that this framework of metrics be incorporated into FDA’s inspection protocol as a roadmap for investigators to evaluate drug manufacturing and control operations during an inspection.
Here’s a demonstration of how you can gain powerful insights from aggregating metrics through the use of a heat map:
Every step in creating a heat map is given in this easy-to-follow video. The heat map can be used for…anything, but we chose to walk through a combination product risk profile example. You can apply this video to any product you have and any aspect you want to assess.
BACKGROUND
On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law, expanding FDA’s ability to safeguard and advance public health.[1] The Act provides FDA with the ability to collect data and information from pharmaceutical companies prior to or in lieu of an inspection (FDASIA Title VII, Sections 704, 705 and 706). In February 2013, FDA announced its Quality Metrics Initiative[2], in which it engaged the pharmaceutical industry to develop a list of data FDA should request from pharmaceutical manufacturers to assess product quality risk and, therefore, aid in its risk-based resource allocation decisions. Additionally, the data requested could provide an indication to FDA of risks to drug supply disruption and can assist investigators in defining where to focus inspectional time spent in the manufacturing plants for more efficient and effective inspections.
As a result of FDA’s outreach to the industry, several initiatives were undertaken to define, collect, and analyze a wide array of quality metrics that could be used by FDA. Several organizations, including: the Pharmaceutical Research Manufacturers Association (PhRMA), the Parenteral Drug Association (PDA), the Generics Pharmaceutical Association (GPhA), and the International Society for Pharmaceutical Engineering (ISPE), proposed information and metrics for FDA consideration.
During the March 2014 FDA/Xavier University PharmaLink Conference, Russ Wesdyk from FDA’s Center for Drug Evaluation and Research (CDER) presented the following potential data FDA could request from the industry: lots attempted, lots rejected, lots reworked, out of specification results, and lot release results invalidated due to laboratory error or anomaly.[3] Although FDASIA gives FDA the authority to review the data collected in lieu of an inspection, Xavier University expressed in an April 2014 proposal to FDA[4] the importance of reviewing the data during an inspection in order to ensure proper context.
In May of 2014, the Engelberg Center for Health Care Reform at the Brookings Institution hosted a discussion among industry representatives and FDA officials entitled “Measuring Pharmaceutical Quality through Manufacturing Metrics and Risked-Based Assessment”[5] to assess the compilation of data proposed by various organizations.
In June of 2014, Xavier University and PwC launched a metrics initiative with 30 industry professionals such that output could inform decisions and trigger action with the following three goals:
Identify metrics that would enable the industry and FDA to understand proactively the risk to product quality
Assess risk to product quality across the total product lifecycle to drive a mindset of designing quality in products at the source
Provide FDA information to assess during an inspection and, therefore, review in context
On July 28, 2015, FDA issued a draft guidance to the industry entitled “Request for Quality Metrics,”[6] which stated that the metrics collected by FDA would be used to: (1) help develop compliance and inspection policies and practices; (2) improve the Agency’s ability to predict and, therefore, possibly mitigate future drug shortages; and (3) encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing. The following metrics were proposed in the draft guidance:
Lot Acceptance Rate
Product Quality Complaint Rate
Invalidated Out-of-Specification Rate
Annual Product Review on Time Rate
Xavier University and PwC maintain the position that it is important to assess risk to product quality data during an inspection and, thus, in context. The attached proposal provides the Xavier University/PwC recommendation to FDA and the industry on how to use the output of the metrics to inform decisions and trigger action.
TEAM MEMBERS FOR THE PHARMACEUTICAL METRICS INITIATIVE (THE FOLLOWING MEMBERS ARE LISTED WITH THE AFFILIATIONS AND TITLES THEY HAD DURING THE INITIATIVE):
Kankshit Bheda, Manager, Health Industries Advisory, PricewaterhouseCoopers
Grace Breen, Vice President Corporate Quality, Impax
Laura Cannon, Senior Director, Quality, Teva
Brian Carlin, Director, Open Innovation, FMC
Dee Carri, Founder and Director, Torque Management
Patrick Crowley, Owner, Callum Consultancy
James Horger, Senior Director, Quality Systems and Compliance, Mallinckrodt Pharmaceuticals
Dan Jordan, Director of Product Quality Management, Shire Pharmaceuticals
Anil Kane, Executive Director, Global Head of Formulation Development, Patheon
Jonathan Lee, Senior Associate, PricewaterhouseCoopers
Kim Mandrell, Senior Project Manager, Mallinckrodt Pharmaceuticals
Mike Markham, Associate Director Analytical Research, Adare Pharmaceuticals
Sean McCrossen, Chartered Chemist, IEXA100 Consulting
Andrew McNicoll, IEXA100 Consulting
Joseph Northington, Head of Quality, Purdue Pharmaceuticals
Jamie Wilson, Director, Global Quality Assurance, Navidea Biopharmaceuticals
Bob Zinser, Vice President for Commercial Technology North America, Patheon
The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.
