Remediating quality issues in pharmaceutical manufacturing

Building and maintaining quality is one of the top priorities for pharmaceutical manufacturers. To meet the quality expectations of regulators such as the FDA and EMA, companies often do activities such as hiring compliance experts, drafting quality plans, and establishing a quality management system. But how can they prevent any quality failures or address them in a proactive way?

Quality remediation plans are the strategies that identify, evaluate, and rectify issues related to regulatory compliance and quality across the supply chain. In this article, we summarize how pharmaceutical manufacturers can measure the performance of their quality systems and the most common steps to take while addressing issues.

What are Quality Key Performance Indicators?

To assess their quality system, pharmaceutical manufacturers must establish quality objectives aligned with current regulations. These quality goals must be monitored through a dashboard showing Key Performance Indicators (KPIs) that identify drops in performance or sudden indicator changes.

While there are many ways to measure quality in pharmaceutical manufacturing, most KPIs can be classified into five categories: risk, quality response, cost of quality, productivity, and quality culture.

KPI Category	Example of KPI
Risk	# of required audit actions # audit score # outstanding compliance and risks # overdue risk assessments # of recent product changes that may impact quality.
Quality Response	#customer satisfaction score. # product complaints. # overdue issues #time to respond to issues. # time to solve issues.
Cost of Quality	# cost of poor quality (costs associated to incidents, complaints, recalls, lost productivity). # cost of high quality (costs associated to achieving top quality standards)
Productivity	# time to respond to quality evaluations (internal/external) # completed trainings on quality # lot acceptance rate # invalidated out-of-specification rate # overdue audit findings # overdue trainings # overdue quality issues
Quality Culture	# team training scores. # time taken to address quality issues. # quality awareness scores.

By tracking and analyzing quality KPIs, companies can pinpoint gaps in quality early and address them proactively.  

Remediating quality issues

Manufacturers should not wait for an external quality audit to create their quality remediation plan. Remediation activities can have more goals than just fixing regulatory problems, as they can help companies meet updated standards, forecast the potential success or failure of submissions to regulatory bodies, and improve an existing quality system. Unlike other industries, in which the focus of quality remediation is to perfect the manufacturing outcomes, remediation in the pharmaceutical context strives to help manufacturers improve their manufacturing processes at all stages. 

Quality remediation is a process that is split into several steps:

1. Prioritizing concerns: Depending on the quality KPIs that are out of the norm, manufacturers should define what issues these indicators entail and decide the order in which they will be addressed, depending on how critical they are and their overall impact on the quality KPIs.

2. Evaluating the supply chain: Manufacturers then should analyze the activities and stakeholders in the supply chain related to the identified issues or that could block their resolution. 

3. Addressing quality gaps: After the issues, related processes, and stakeholders are pinpointed, manufacturers can analyze the root causes behind the quality gap and develop a remediation plan in collaboration with the supply chain actors involved.

4. Launching a work plan: The actions on the remediation plan should be assigned across the supply chain, with actors committing to resolve the issue.

5. Implementing and monitoring: once the remediation plan is launched, manufacturers must continue monitoring quality KPIs to determine the status of the resolution of identified issues.

Through quality remediation plans and quality KPIs, pharmaceutical manufacturers can build a quality of culture that is ready to address customer product complaints, has clear lines of communication with supply chain actors, and strives to improve the processes that impact quality across production. These proactive actions not only improve how manufacturers can manage quality concerns, but also make production more consistent, and contribute to meeting the quality standards set by regulatory bodies.

Quality at J. Molner

At J. Molner, we employ a dynamic and comprehensive approach to achieve our quality targets. We proactively conduct internal audits, regularly review our procedures and risk assessments, and monitor the ever-evolving regulatory landscape. Clear and consistent management oversight ensures critical quality metrics—such as overdue procedures, out-of-specification results, deviations, and routine training compliance — are tracked and addressed. Additionally, we consistently evaluate and enhance the effectiveness of our Corrective and Preventive Actions (CAPA), implementing timely changes when necessary. 

Given our collaboration with Contract Manufacturing Organizations (CMOs) for drug product manufacturing, our distinct yet interconnected quality management systems ensure consistent and high-quality products across all sites and throughout each stage of the product lifecycle. 

Ultimately, our most valuable asset remains our dedicated employees, who actively identify potential quality concerns, suggest impactful improvements, and proactively manage quality KPIs across all teams and departments.