The FDA has issued a white paper on “CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development.” The paper details a program the center intends to establish whereby the goal is to promote QMM throughout the industry. Lachman recently issued a blog relating to this initiative that can be found here.
A natural question to raise when considering the above program is what are the characteristics of a pharmaceutical company that has a mature QMP? One potential indicator is a company that takes a proactive approach to address risks to quality throughout the company’s operations whereby driving a culture of continuous quality improvement versus a company that addresses quality issues in a reactive manner. As you can imagine, such a proactive approach will more likely head off supply chain issues (a motivator for the CDER program) due to quality incidents.
Following on from this, it should be asked if the company one works for has such a proactive approach, then how would this be demonstrated? One indicator could be to assess how often are preventative actions taken by a firm to address potential risks to quality and/or to drive continual quality improvement. It is understood that corrective actions are a necessity when addressing quality incidents but too often companies forget the “PA” within CAPA. Preventative actions can mitigate potential failure modes that have been identified through risk assessments where there has yet to be a quality incident, but risk nevertheless remains. The above white paper references “Technical Excellence” as one of the five (5) practice areas that CDER proposes to include in their prototype assessment to determine the maturity of a company’s QMP as the adoption of technological advances can be key to driving continual quality improvements via preventative actions.
One area where technology is key in driving quality improvement is Data Governance. A firm that understands how technology can be utilized to enhance data integrity controls over the lifecycle of data mitigates the risk of data integrity incidents and agency citations. For example, using technology to drive automation such as the systems and processes that generate, process, report, store data can minimize the need of higher risk manual processes, providing a distinct quality advantage. This is particularly apparent where data needs to be transferred between systems: a validated automated process whereby data is transferred between, for example, a chromatographic data system (CDS) and LIMS presents a lower risk of Data Integrity risks vs manual data entry of the CDS data into LIMS. Another example is the utilization of Process Analytical Technology (PAT) which is a system for designing, analyzing, and controlling manufacturing through timely measurements of critical quality and performance attributes of raw and in-process materials/processes to ensure final product quality. PAT facilitates a greater understanding of the manufacturing process and through continuous process verification can drive further optimization of manufacturing control strategies to enhance product quality throughout the product lifecycle.
The key is to continually evaluate where technology could be utilized to address existing quality risks with your systems/processes/procedures to enhance control and, thus, drive quality improvements.
If you have any questions relating to Quality Management Maturity program, Lachman Consultants can help you! Please contact Lachman Consultants at LCS@lachmanconsultants.com.
Note: This post is a follow-up to provide additional context to the September 1, 2023 Lachman post here.