Ajinomoto Bio-Pharma Services

Jennifer Vavala

In August of 2023, the FDA communicated a new white paper CDER’s Quality Management Maturity (QMM) Program:  Practice Areas and Prototype Assessment Protocol Development. This white paper promotes QMM at drug product manufacturing organizations to help strengthen the drug product supply chain and reduce instances of drug shortages. QMM is achieved through robust business practices, predictive detection methods, and healthy quality culture.   

Quality Assurance (QA) has been and remains fundamental in creating and assuring customer confidence in drug products. QA focuses on planned and established processes that improve and maintain quality across functional units in an organization. Quality Control (QC) primarily involves product or process testing to ensure standards and specifications for safety and efficacy are met.

QMM is an assessment of a drug product manufacturing organization and its maturity of operations. It is not used to assess GMP compliance, which is already a foundational requirement. QMM assessments determine how quality is utilized throughout an organization. It gauges quality culture as a vital part of operations.

If an organization is unsure of the maturity of its quality model, an assessment can start with a simple question: Is it reactive or proactive? A reactive organization has delayed detection with heavy reliance on QC data. A proactive organization has early detection methods and systematic quality by design. Reactive organizations should assess and make appropriate changes to their quality program. Influencing change can be challenging and time consuming. Where to start?

Moving towards QMM, a Quality Improvement Plan (QIP) can be a map to strengthen a Quality Management System and quality culture. Simply put, a QIP is an organization’s plan for developing and/or improving processes. QIPs begin with measuring past performance and identifying the opportunities for improvement. Recognizing pain points (current state) is required to understand what counter measures are needed to achieve strategic outcomes (desired state). QIPs go beyond the standard continuous improvement model to enhance overall quality. QIPs require in-depth understanding of existing problems and intended results.

For example, issues that could contribute to an immature quality model may include missed quality event targets, lack of phase appropriate processes, manual systems, and absence of risk management plans to discharge inherent risk(s). 

Counter measures to address these could result in strategic outcomes that include creation of industry leading systems, improved cycle times, stronger supply chain relationships, and enhanced quality risk management.

If systemic changes are required to meet intended results, it may be useful to break the QIP into “buckets” to accurately understand existing challenges in each area while maintaining a streamlined document. Some options include:

● People (build depth of knowledge, develop and retain talent)

● Operational and Quality Systems (areas to modernize, reduce human interaction, or implement statistical process control)

● Governance and Oversight (meaningful metrics, implement self-assessments, or improve Management Review Meeting inputs)

● Knowledge Retention (succession planning and capturing legacy information)

QIPs are a comprehensive way to document an organization’s pledge to its quality strategy and journey to QMM. It should capture both short and long-term objectives completed over the course of 1 to 3+ years. QIPs also capture Senior Management’s understanding of their obligations in drug product manufacturing oversight. According to ICH Q10, Pharmaceutical Quality System, Senior Management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve quality objectives. If an organization is embarking on change to improve the quality program, it is imperative to involve Senior Management to ensure allocation of the proper resources to align on and achieve the desired outcomes.

When drug product manufacturing organizations implement QIPs and evolve with QMM in mind, the result is stabilized supply chain and reduced quality troubles. This results in a reliable and safe drug supply that patients can count on.