Using Your QMS to Support cGMP Compliance

In FY 2023, the majority of warning letters issued to pharmaceutical manufacturers by the U.S. Food and Drug Administration cited current good manufacturing practice (cGMP) violations.

Some of the top violations highlighted in those citations include inadequate laboratory controls, failure to establish written procedures, and improper equipment maintenance.

It’s not altogether surprising, given the vast number of requirements pharmaceutical manufacturers must meet to avoid problems during FDA inspections.

The answer for companies wanting to improve their compliance posture: a strong quality management system (QMS) built specifically for regulated industries.

That’s because compliance with cGMP regulations is anchored on several key areas aligned closely with the features of a modern quality management system (QMS):

1. Document Management
2. Corrective and Preventive Actions (CAPA)
3. Risk Management
4. Employee Training
5. Supplier Quality Management
6. Complaint Handling
7. Change Control
8. Internal Audits

Each of these components is an essential pillar of compliance, which we explore in more depth below.

Watch a free webinar on Automating Complaint Management for Life Sciences: A Best Practice Approach

Documentation and Recordkeeping

It’s hard to overstate the importance of documentation and recordkeeping in the context of FDA compliance. If cGMP compliance is a house, documentation is the foundation, providing a demonstrated record of compliance while supporting traceability and facilitating audits.

Look at any FDA warning letter, and you’re likely to see cGMP violations around documentation and recordkeeping. QMS software can help ensure compliance in several key areas, providing:

• A centralized location for all standard operating procedures (SOPs)
• Automated workflows for document creation, approval, revision, and archival
• Role-based access control to prevent unauthorized access or editing of records
• Full traceability with audit trails to ensure compliance with requirements around electronic records and traceability

While many manufacturers still rely on paper documents and records, this often leads to common violations around having accurate, contemporaneous, and legible data. QMS software, on the other hand, ensures data integrity and alignment with ALCOA standards, preserving a detailed compliance history that’s helpful both from an internal perspective as well as streamlining external audits.

Corrective and Preventive Action (CAPA)

Corrective and preventive action (CAPA) deficiencies are a top driver of cGMP violations, whether it’s incomplete documentation, slow response times, or ineffective solutions.

CAPA software designed around a closed-loop process helps avoid these problems, ensuring corrective actions are integrated with other related quality processes so issues can’t fall through the cracks.

Key elements of QMS software to evaluate in terms of CAPA functionality include:

• Root cause analysis workflows using different tools such as 5 Whys, 8D and failure mode and effects analysis (FMEA)
• The ability to initiate a corrective action from any process, including nonconformance tracking, complaints, and supplier quality management
• Defined roles and responsibilities for each step in the CAPA process, plus automated escalation of overdue tasks to keep the process on track
• Risk assessment tools that can be added to any CAPA to ensure proper prioritization of corrective actions

Risk Management

FDA requirements emphasize a risk-based approach to quality, underscoring the need for a QMS with built-in risk management tools to help manufacturers assess and prioritize risks in the system.

A QMS built for FDA compliance will provide a number of capabilities in this area, such as:

• Workflow-driven processes for systematically identifying, assessing and controlling risk
• The ability to leverage risk assessment tools within other QMS solutions such as audit management, change management, complaints, corrective actions, and deviation or nonconformance tracking
• FMEAs with automated risk priority number (RPN) calculations
• Color-coded heat maps on risk matrices to quickly identify unacceptable risks
• Automated alerts and tasks to expedite the review of risk items and assign issues according to pre-defined criteria such as risk level, role, or product type

Personnel and Training

Ensuring that personnel are trained on cGMP requirements is an essential part of compliance, and an element likely to come up during any FDA audit. It’s not uncommon for auditors to spot-check training records, and you also want to make sure your employees are prepared for any in-person questions the auditors may pose to them.

There are several ways training management software in the QMS can help, including:

• Generating automated training assignments based on role, department, or group
• Providing real-time dashboards for tracking process
• Creating a complete record of all training activities
• Integrating post-training assessments to verify comprehension of training materials
• Sending alerts for assigned and overdue training responsibilities and escalating issues to management as necessary

Supplier Quality Management

Ensuring supplier quality is a cornerstone of cGMP compliance, given that supplier performance can have an enormous impact on product quality and safety. Ultimately, it’s important to recognize that your quality processes must extend beyond your own facilities to ensure incoming material quality and prevent product risks.

Supplier quality management software within the QMS can help you close the loop on supplier issues and proactively monitor supplier quality with tools such as:

• A secure supplier quality portal for communicating with suppliers and contract manufacturers
• The ability to generate supplier corrective action request (SCAR) documentation and track action items to completion
• Automatic updates to suppliers on any changes to policies, quality agreements, or specifications
• Supplier scorecards for rating and tracking supplier performance over time
• Detailed data on incoming inspections to identify high-risk suppliers and any necessary actions, plus alerts and documentation for out-of-specification (OOS) inspection finding
• Comprehensive qualification processes and checklists based on component or product risk
• Supplier audit tracking to verify supplier quality practices, including the ability to upload offline audit results to the supplier record

Complaint Handling

Complaint handling is an essential part of cGMP compliance, particularly as it relates to adverse events. Depending on the size of your company, managing complaints can require significant resources in terms of reviewing complaints.

The QMS can help support efficient and effective complaint handling with standardized workflows to automatically route complaints through each step in the process, including:

• Intake: Collect all relevant data needed for investigation and reporting.
• Review: Determine whether the complaint is valid and/or reportable using decision trees to route the complaint for either further investigation or closure.
• Investigation: Route complaints that meet established severity thresholds through an investigation workflow and assign tasks to responsible individuals.
• Reporting: Submit any required adverse event data using automated report generation.

Change Control

Compliance with cGMP requirements requires defined change management for production procedures, as well as investigation of any changes that could potentially affect quality.

A strong change control process helps ensure any modifications made to drugs have been evaluated from a risk perspective, preventing unintended consequences to patients. Undocumented changes can lead to compliance gaps, which is an area where QMS software can help with change control software that:

• Centralizes change control activities in one place for easy tracking
• Facilitates collaboration and approvals among subject matter experts (SMEs)
• Allows you to incorporate risk assessment tools into change control processes
• Integrates with other systems such as ERP, PLM, CRM and LIMS for full visibility
• Provides time-stamped audit trails for a complete record of change history

Audits and Inspections

A rigorous internal audit program is an essential piece of cGMP compliance, given the wide number of requirements manufacturers must adhere to. Internal audits help identify gaps and drive continuous improvement, while also ensuring the organization is ready for FDA inspections. It’s true both from a documentation perspective as well as in terms of helping proactively identify problems that could come up during external inspections.

Audit management software helps organizations plan and execute internal audits with ease, so companies can be sure they are on top of compliance requirements and ready for visitors such as FDA inspectors or ISO auditors. Companies can use the QMS to digitize their audit processes with:

• Real-time dashboards to track open audit findings
• The ability to flag audit findings by risk and integrate them with CAPA workflows
• A centralized repository of audit plans, tasks, findings and reports
• Automated action item tracking, email alerts, and escalations to minimize audit cycle time
• Print-ready audit reports with comprehensive detail, including the ability to attach document, photo and video evidence
• Offline audit capabilities with direct uploads to eliminate manual data entry

Conclusion

Adherence to cGMP is the cornerstone of pharmaceutical safety, and thus a key focus for companies and regulators charged with safeguarding public health. The challenge for manufacturers is ensuring their QMS helps them meet requirements as well as reduce the manual labor involved with traditional pen-and-paper quality processes.

A QMS built for regulated industries can provide a foundation for cGMP compliance, providing a closed-loop, risk-based approach to ensuring quality across the product lifecycle. Moreover, it can transform the quality process itself, eliminating manual bottlenecks while making it easy to access the insights needed to drive continuous improvement.

Download a free case study to learn how one global pharma manufacturer eliminated paper-based processes

About the Author

Stephanie Ojeda is Director of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 15 years of leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.