Product quality reviews (PQRs) are key to unlocking quality success for pharma companies. It is a report card (in the literal sense) that qualifies a company’s adherence to cGMP standards.
Usually an annual preparation, PQRs can be done more frequently for higher effectiveness and control. The idea of the PQR is evolving, shaping up towards achieving a culture of quality & compliance with regular review.
APQR Mandate – A Gateway to Quality Success
APQR is more than a mandate, it is a mirror to procedural flaws. As APQR is an elaborate process, it ensures a deep dive into every critical aspect of manufacturing. This helps companies identify potential discrepancies at an early stage and take corrective actions to prevent bigger future issues.
Quality reviews are critical. They verify process consistency, ensure product quality, and identify improvement opportunities. In the complex framework of pharmaceuticals, every minute aspect related to product quality matters. With such complexity and precise requirements, Annual Product Quality Reviews (APQRs) are approached as a legal requirement.
The FDA Guidance for Industry Q10 has detailed guidelines for periodically conducting product quality reviews. It is a mandatory ritual for all the regulated pharmaceutical products manufactured at a GMP (Good Manufacturing Practices) site.
Regulatory bodies have stringent guidelines for preparing APQRs – and it is worth it. By assessing the consistency of manufacturing processes, quality review reports ensure the safety and quality standards of drugs. Hence contributing to overall patient safety. It is rigid, it is elaborative, and it is NECESSARY.
How is product quality review evolving?
Product quality reviews (PQR) are manual and annual preparations at most manufacturing sites. However, keeping pace with technology and a growing need to build a sustainable quality culture, APQRs are undergoing a massive transformation.
Automated APQR processes allow companies to rise above siloed data systems. Organizations can now be at ease with the process of APQR preparation with digital tools that simplify data collection, allowing more time to review data and extract insights for timely decision-making.
Since manufacturing 4.0 demands more precision in drug safety, APQRs must be extra-stringent in identifying gaps for better compliance. While manual tasks are being taken over, facilities will be able to save more time and prevent errors. This makeover of the APQR process comes with an array of complementary benefits.
Anytime reviews – Annual to Anytime is the new norm for APQRs. This evolution has been remarkable in aligning production with the stringent FDA requirements.
Instant reports – One-click reports are now possible with a digital APQR. With anytime access to reports, users can detect issues earlier and save on batch recalls.
Quicker approvals – Pre-defined systems accelerate the approval process for quicker generation of APQR reports.
Zero paper reports – Digital APQRs promote paperless reports with e-signatures that are also compliant with the regulatory guidelines.
Audit trails – With digital APQR reporting, all the steps involved in its generation are traceable, maintaining detailed audit trails for regulatory compliance.
Scalable solution – Product quality reviews can now be done easily and quickly despite increasing data generated by companies.
Look AT Data, Not FOR Data
With tons of data generated every second, looking for data from different sources is next to impossible. Apart from being time-taking, it leaves an open end for errors and integrity issues.
With automated APQR systems, managers can now look AT data with a sorted visibility of critical, decision-making parameters.
Time Saved is Money Saved
The PQR process is resource heavy. Every annual preparation of the PQR consumes 3 months of a personnel’s time. This sums up to increased costs and a risk of discrepancies during the process.
Automated Anytime Product Quality Reviews are designed to make the lives of quality personnel easy, enhancing product safety and ensuring assured success. Like how electronic toll systems have automated toll collection to ensure minimal wait time for vehicles, automated PQRs have put quality reporting on the FAST lane.
CaliberAPQR – The 3-minute Game Changer in Quality Reporting
Turning the previously impossible into now possible, CaliberAPQR can derive product quality review reports within 3 minutes. Powered by automatic data ingestion and compliant behavior, the tool helps save time, brand reputation, and contribute to a sustainable ecosystem.
Our customers have experienced this in reality.
- Easy and quick access to reports
- Extensive statistical abilities
- Better decision-making
- Confident audits
Pioneering Anytime PQR for the regulatory industry, CaliberAPQR gives actionable insights with a single click for informed decision making. It enhances traceability, displays trends, provides statistical calculations, and makes quality reporting simple yet compliant.
1 click, 3 minutes = Successful Quality Reporting
Caliber’s Quality-first approach resonates with self-governed quality for enterprises. CaliberAPQR echoes FDA’s vision of organizations having a quality mindset. By automating APQR processes, it ensures that quality reports are just one click away. By extracting data within minutes from various data sources, it ensures data integrity and compliance. CaliberAPQR is designed to make quality a habit.
