Product Quality Review (PQR) Service
Are you looking for support to perform your annual Product Quality Reviews (PQR)?
QbD Group offers a fully streamlined process where our experts analyze and review your data, helping you maintain regulatory compliance and identify opportunities for improvement.
Don’t hesitate to contact us for more information.
What is a Product Quality Review?
A Product Quality Review (PQR) is a comprehensive evaluation of the production and control processes of a pharmaceutical product. It verifies process consistency, identifies trends, and ensures ongoing compliance with regulatory standards.
By conducting PQRs, QbD Group helps you evaluate every stage of production—from raw materials to the finished product—delivering detailed reports with action plans for improvement.
PQRs are critical for maintaining product integrity and safety, and they help pharmaceutical companies remain compliant with industry regulations.
For manufacturers and Market Authorization Holders, QbD’s PQR service can alleviate workload spikes and provide peace of mind by ensuring thorough and reliable quality assessments.
Why is Product Quality Review Important?
- Verification of Product Quality: Confirms consistency of quality attributes across batches.
- Identification of Areas for Improvement: Highlights opportunities for process optimization and corrective actions.
- Ensuring Regulatory Compliance: Meets the mandatory yearly requirement for product quality evaluations.
- Trend and Anomaly Detection: Helps identify outliers or emerging trends that require attention.
Why QbD Group?
By choosing QbD’s PQR service, you also gain access to a host of benefits designed to streamline your quality review process and ensure compliance. Here are some of the key advantages:
- Expert Knowledge: Our team brings extensive expertise, ensuring precise and thorough data evaluation.
- Ready-to-Approve Reports: Receive comprehensive reports, complete with proposed action plans, ready for your approval.
- Workload Management: Outsourcing PQR to QbD reduces the peak workload of your QA department.
- Comprehensive Service: We manage all aspects—from resource training to activity planning—making the process effortless for you.
How Does It Work?
Our PQR service is designed to be flexible, allowing you to choose options that fit your needs. You can decide whether to use QbD’s standardized PQR report templates or your own, and whether to normalize data internally or let our experts handle the pre-analysis processing. Here’s how the process works:
- Information Intake: We provide a detailed list of the required information, and you prepare the data.
- Data Check: Our experts conduct an administrative check to ensure all required data is present.
- Data Processing: QbD conducts the statistical processing of your data.
- Review and Analysis: Comprehensive review and analysis by our experts.
- Report Creation: A fully comprehensive report is generated, complete with a proposed action plan.
- Client Approval: The report is sent to you for review and approval.
- Yearly Insights: Each year, QbD will provide insights into trends across PQR reports over the years.
This structured yet flexible approach ensures that you remain in control while benefiting from our expertise at every stage of the process.
Contact us
To learn more about how QbD’s PQR service can enhance your quality management, schedule a consultation with our experts.
We’ll assess your specific needs, discuss implementation strategies, and demonstrate how our services can benefit your organization.