QMM Updates

FDA has recently published an update on their ongoing development of the Quality Management Maturity (QMM) assessment protocol, which has further refined the elements to be included in the evaluation of a site’s advanced pharmaceutical quality system (PQS).  The Agency has outlined five elements that are likely to be included in the eventual assessment protocol:

1.       Management Commitment to Quality

2.       Business Continuity

3.       Advanced Pharmaceutical Quality System (PQS)

4.       Technical Excellence

5.       Employee Engagement and Empowerment

These elements should come as no surprise, as they have been communicated in some form in previous QMM and/or drug shortage publications; and are fully aligned with the principles already described in ICH Q8, Q9 and Q10.  The question is not the value in investing in such elements, but rather how to perform an objective evaluation and ensure consistency, considering the diversity of manufacturing processes and varying levels of resources available to manufacture different product classes (e.g., generic vs. innovator). 

This will no doubt be the biggest challenge to implementation of the program, and will eventually have to settle on achievable goals for each element.  In my opinion, this will include an evaluation of the tools provided to site staff to achieve success in each area (it will not revolve around how well site management can speak to the elements) – but rather what are you doing about it.  One meaningful management metric for element #4 might be “number of human hazards existing within our CPP/CQA workflows”.  Success in each area will depend on the effective use of the “enablers” outlined in Q10:

1.       Knowledge Management (effective utilization of unstructured data/information)

2.      Quality Risk Management (focus on design, operation, and monitoring of key workflows)

For those sites operating with limited resources, you might be wondering if you can compete within the eventual QMM program.  The answer is = absolutely.

Answer = By embracing and investing in the principles of “Non-Invasive Data Governance”, each of the five elements above is addressed through efficient use of limited resources.  It involves two key principles:

1.       Integrating existing processes into the formal Quality System

2.       Re-directing existing resources to achieve process ownership (away from non-value-added activities and into Quality-focused-activities)

Disclaimer: As a training company focused on element #5, I obviously have a conflict of interest here. 

I’m excited to see how the QMM protocol evolves, especially as they try to tackle the problem of objectivity.  If they design the protocol to include a measurement of how the site actively works to reduce risk to patient safety (drug shortages + safety/efficacy) through the introduction of new QRM and KM tools, then I believe this years-long initiative will result in a significant return on investment.