Brief Summary of FDA Quality Management Maturity Program

United States FDA has a pivotal role in providing guidance for pharmaceutical quality attributes and defining new ways to improve the quality by publishing new regulations for quality enhancement. Quality management maturity is also one of many new guidance that the US FDA has adopted to enable pharma industry to focus on minute quality matters.

While Quality Management System is an important mechanism that establishes quality in Pharma organization by implementing predefined procedure, systems and practices. However, QMS does not specify about how well an organization has applied quality principles in their routine operational procedures, the QMM solves this problem and provide the current level of quality of a particular organization. 

It aims to raise awareness in all areas of Pharma processes and devise mechanism to improve quality and reliability

What is quality management maturity?

Quality Management Maturity is defined as the degree to which quality practices and principles have been applied in an organization. In simple words, it is the present state of quality for an organization, and describes the current willingness in fulfilling quality requirements, across various departments

Quality Management Maturity is a step further in implementing quality systems for the pharmaceutical industry. Developed by United States FDA, it focuses on assessing the current quality state and suggesting improvements, where required. 

A high degree of maturity means an organization has integrated maximum quality practices in their businesses & manufacturing operations, and is producing high quality products. As a result, the pharma organization is rewarded by increased market share, good reputation and higher rates of acceptability by regulatory bodies , as compared to other pharma organizations.

History

The basis of QMM is the FDA report, "Drug shortages: Root Causes and potential solution'. In this report, the FDA identified various root cause for drug shortage, and one of them was

 "The market does not recognize and reward manufacturers for mature quality systems that focuses on continuous improvements and early detection of supply chain issues"

In this report, the FDA suggested "Developing a rating system to recognize drug manufacturers to invest in Quality Management Maturity for their facilities"

After these findings, the FDA started working on it, and in 2021 the FDAs "Center for Drug Evaluation and Research" started an initiative to develop Pharmaceutical quality rating system, and became known as "Quality Management Maturity". 

The man advantage of QMM, as proposed by FDA CDER to allow pharma product buyers to differentiate among pool of manufacturers on the basis of quality ratings. As a result pharma organization with higher quality rating is incentivized for establishing quality practices and following risk management frameworks, by increased customer trust, more market share and priority over other pharma manufacturers that have low quality rating.

Advantages

Let's look at some advantages of QMM

Helps prevent drugs shortage

One of the reasons for drugs shortages are quality issues in pharma organization that leads to delay in routine production process, until desired quality attributes have been implemented and quality metrics achieved.  Additionally, improper quality practices also result in product recalls, further delaying the drug supply to the market.

Quality Management Maturity uses a rating system for an organization that describes how well an organization is implementing quality principles continuously in their routine operations. Rather than just implementing quality principles, it allows a pharma organization to measure GMP and Quality Principles, and differentiates organization that has lower level of QMM. 

Patient and consumers can use Quality Management Maturity to identify and shortlist pharmaceutical supplier with high rating and selecting for their drug supply. The organization will supply continuously, and will suffer less delay and pause, due to the high QMM level, in whatever circumstances and helps to prevent shortage in the market

Continual improvement

The basis of QMM is continual improvement in their output and improving their routine processes, which calls for regular investment in their various sectors such as personnel, maintenance, materials and training.

The traditional Quality Management System provides guidelines for implementing quality system in their routine operations. While it focuses on continuous improvement there is no system that help a pharma manufacturer to rate or assess its overall quality implementation and provide a reference to customer to make its judgement about a particular pharma organization. Regulatory investigators inspect quality in organization, and only inspect it for their purpose and do not provide it as a reference to others. 

QMM provide an opportunity for third party customers to gauge  the organization in terms of implementing quality, and higher QMM levels indicate a healthy continuous process.

Increased market share

It is common in the market to respond positively to organization and companies that use innovative ways and invest in technology for their operations. Additionally, investors also prefer those companies that have high quality rating and continuously invest in new latest trends and processes, like QMM

Organization that have QMM in place, have more opportunities to grab market share as compared with other organizations do not have quality ratings system.  It also helps an organization to have better customer and supplier relationship, and investors are more willing to invest in these organizations.

Goals of a Quality Management Maturity program

Let's discuss the goals of QMM program and what FDA intends to expect. 

● Encourage developing a strong quality mindset

● Recognize entities that have implemented QMM practices and acknowledge those that continuously improve their system , process and operations

● Minimize risks faced by products to ensure reliable market supply, especially in emergency that can cause disruption

● Suggesting actions for growth opportunities 

Brief Summary of FDA Quality Management Maturity Program

As discussed earlier, FDA initiated the Quality Management Maturity in response to a report on drugs shortages.  Let's discuss its attributes for an effective implementation. 

For the QMM, the FDA CDER has identified following areas of interest

● Management Commitment to Quality

● Business Continuity

● Advanced Pharmaceutical Quality System (PQS)

● Technical Excellence 

● Employee Engagement and Empowerment

The above mentioned areas were identified through rigorous review process, including 

● Examining literature related to Quality Management System

● Surveying external stakeholders

● Feedback and evaluating data from the pilot programs.

Let's discuss the area of interest as identified by the FDA 

Management Commitment to Quality

The management in any organization has a definite role in ensuring Quality, Safety and Purity of the drug product. Management is also responsible to establish a quality policy objective and to make sure that the quality objectives are followed with the business objectives, and prioritizing them. Management should also allocate proper resources and facilitate clear and open communication

Assessment related to management commitment include

● How Management prioritize and establishes quality goals and policies

● Communicating this goals to the staff of all level throughout organization

● How and when management review is performed

Business continuity

Business continuity is the ability of a business to perform successfully in disruption, and how it sustain these disruption to provide regular supply of drug products.

It is necessary for pharma industry to devise business continuity plans to prevent disruption in supply chain and minimize economic losses. This can be done by building mature systems, which in turn depends on identifying hazards, analyzing, and mitigating risks, implementing good governance and monitoring systems . 

For the Quality Management maturity, it can be achieved by reviewing

● How effectively an organization has built redundancies

● Understanding and mitigating risk associated with supply chain

● Effectiveness of established preventive maintenance system

● Frequency of disruption in production processes.

An organization focusing on the above mentioned points will hopefully become a quality mature organization that can effectively understand the risks posing business operations and mitigating techniques for business continuity.

Advance pharmaceutical quality system

Advanced Pharmaceutical quality system is the name of combining quality principles and risk management approaches for achieving high degree of reliability, and results in non-disruptive drug supply.  Its main advantages that it increases efficiency of a pharma drug manufacturer and results in improved performance

An advanced PQS may be applied by using

● Quality risk management

● Monitoring product performance and quality

● Effectively using CAPA

● Effective implementing change management system

Technical excellence

Technical excellence of an organization refers to acquiring necessary knowledge and skill for efficiently performing organizational processes, and producing quality product. It also includes adopting latest innovative technology in routine processes to solve problem related to the manufacturing operations

A quality mature organization makes sure that information across their organization is accurate, consistent and available when required. Additionally how an organization use information for implementing latest technology, systems, and apply innovative solution is critical for implementing technical excellence across all levels of human resource

Employee engagement and empowerment

Employee engagement is the name of playing an active role by all employees of an organization in implementing quality policy and achieving quality objectives, rather than just dedicating this job to a particular group of employees.

In Quality Management Maturity, employee of all levels in an organization take an active part in suggesting ways to improve and implement quality throughout the manufacturing operations. Management also creates an environment where every employee consider himself as an important team member and give them the confident to share their thoughts and experience. 

As a result, an engaging employee finds himself elevating in his or her career path with increasing knowledge, experience and skill

About the Author:

Muhammad Asim Niazi

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.