Mitigating Compliance Risk with Your Quality Management System

June 2, 2020

In the first blog of this three-part series, “Overlooking Your QMS Could Cost You,” we discussed the cost of “good” versus “poor” quality, and the importance of investing in a “good” Quality Management System (QMS).

By spending your resources and time on prevention and improvement (“good” quality) you are ultimately focusing on mitigating risk. Risk that could have a devastating impact on your trial, drug, or device.

The Importance of Developing a QMS with a Risk-Based Focus

Risk, as defined by FDA’s Guidance on Quality Systems, is a continuum that requires constant attention.

The FDA concludes that modern quality systems, when coupled with manufacturing process, product knowledge, and effective risk management practices, can handle many types of changes to facilities, equipment, and processes without the need for prior approval regulatory submissions.

Manufacturers with a robust quality system and appropriate process knowledge, can implement many types of improvements. In addition, an effective quality system that lowers the risk of manufacturing problems may result in shorter and fewer FDA and EMA inspections.

When it comes to clinical trials and clinical laboratories, the same risk philosophies have been adopted from the device/drug manufacturing industries. The industry defines risk as any event that may have an undesired impact on patient safety, compliance, or data integrity. Risk mitigation is the process of developing options, actions, and reactions (e.g., quality system documents, investigation documents, training, CAPA, and protocol amendments) to reduce threats to the success of the trial, analytical testing, or conformance of the device or drug to specifications.

A QMS developed with a risk-based focus can help mitigate risk from the beginning of the drug development or device design process and provide a foundation to address issues as they are encountered.

Quality Management System Design

Quality system design establishes a means to maintain compliance and oversight by creating an infrastructure for Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) QMS.

Essentially, your QMS is the embodiment of compliance from beginning to end. A strong Quality System has many components that are critical for mitigating risk and should accomplish the following:

  • Developing a comprehensive quality manual that forms the basis of what the quality system looks like. The manual should detail compliance plans, standard operating procedures (SOPs), corrective action and preventive action plans (CAPA), and safety oversight plans.
  • Advancing quality oversight of activities, such as Clinical Trials, product conformance, product release, labeling, and distribution.
  • Defining the organizational structure where roles and responsibilities are clearly outlined.
  • Establishing the foundation for qualifications and training.
  • Providing a platform for change management that assesses the impact of a change.
  • Outlining the process for investigation, CAPA, query, and amendment.
  • Defining the oversight and management of delegated responsibilities to a contract research organizations (CRO), Contract Manufacturing Organizations (CMO), and vendor management.
  • Creating a risk management plan that details a predefined allowable amount of risk before a response is triggered. Incorporating a process for determining if the risk will have a minor, major, or critical impact on quality. Once the level of risk is assessed, the proper response can be initiated.

Mitigating Compliance Risk with Your Quality Management System: Risk Mitigation Expertise You Can Rely On

A proactive and risk-based approach to a quality system can substantially reduce the chances of your organization falling victim to a catastrophic risk that could jeopardize your trial, drug, or device’s future.

With a robust Quality System in place, you will be able to successfully bring your drug or device to market, while providing a safe and effective treatment for those who need it.

ProPharma’s Life Science Consulting team is made up of subject matter experts who can assist with Clinical and Commercial Quality System designs including risk management, quality manuals, SOPs, CAPA design and processes, risk management plans, and communication plans. We also assist with Quality System implementation and optimization, as needed. Additionally, we can conduct qualifying audits for sites and vendors, routine audits for ongoing trial, CMO, and CRO audits.

Whether your needs are for implementing, maintaining, or remediating a Quality Management System, our risk mitigation experts are here to help. Contact us today for a complete evaluation of your current QMS.

Stay tuned for Part 3 of this blog series, where we will discuss common QMS obstacles and how you can avoid them.


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