Annual product quality reviews (APQR) are one of the most important activities for pharmaceutical companies, connecting them to various regulatory agencies and regulations, as the table below illustrates.
| Agency | Regulations | Scope |
|---|---|---|
| US Food and Drug Administration (FDA) | The FDA requires pharmaceutical manufacturers to conduct APQRs as part of their quality management systems. These documents outline the expectations for conducting APQRs, including the scope, frequency, data requirements, and documentation. | |
| European Medicines Agency (EMA) | EMA mandates APQR as part of its regulatory requirements for pharmaceutical manufacturers operating in the European Union. These documents outline the expectations for conducting APQRs and integrating them into pharmaceutical quality systems. | |
| International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (IHC) | While ICH guidelines do not specifically address APQR, they provide overarching principles for pharmaceutical quality management, which include elements relevant to APQR. These guidelines emphasize the importance of continual improvement, risk management, and quality systems, which are integral to the APQR process. |
Adherence to regulatory frameworks connected to APQR is essential for pharmaceutical manufacturers to ensure compliance with quality standards, maintain regulatory approval for their products, and uphold patient safety.
More specifically, APQRs are conducted annually to:
- Assess the validation state: APQRs help assess the validation state of the processes of the pharmaceutical company’s commercial products.
- Implement continuous improvement: Performing an APQR requires a systematic review of manufacturing processes, test results, and deviations. This process allows for the identification of areas for improvement and the implementation of corrective and preventive actions (CAPAs) to continually enhance product quality.
- Manage risks: APQR helps identify the potential risks associated with product quality, manufacturing processes, and supply chain activities.
- Manage the product lifecycle: APQR requires monitoring trends in quality metrics, stability data, and adverse events to assess product performance throughout its lifecycle.
- Perform regulatory reporting: APQR serves as a basis for reporting product quality information to regulatory authorities during inspections.
- Guarantee regulatory compliance: As mentioned, APQR is a regulatory requirement mandated by agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Ideally, by performing an APQR, a pharmaceutical company will confirm that the product and its manufacturing process retain quality. In instances where issues arise, this review will serve as a basis for taking proactive measures to mitigate the likelihood of future product recalls and regulatory sanctions.
Pitfalls in APQR Processes
APQR plays a vital role in ensuring the quality, safety, and efficacy of pharmaceutical products, as well as maintaining regulatory compliance, managing risks, and fostering stakeholder confidence.
With that in mind, there are common pitfalls in APRQ processes in general, such as:
- Inadequate data collection: The most common pitfall is the failure to collect comprehensive and accurate data due to incomplete or missing data or inconsistent data sources.
- Relying on manual processes: Preparing reports and analyzing data using paper-based systems (and for the purpose of this discussion, we consider Microsoft Excel to be a paper-based system) makes trend analysis difficult and error-prone, which can lead to overlooking important patterns that may indicate underlying quality issues. The process is also inefficient, draining a lot of time and human resources.
- Failure to identify deviations: Without a robust trend analysis, it's easy to miss emerging deviations, which could signify potential quality concerns. This will also make the identification of root causes ineffective for implementing effective corrective and preventive actions (CAPAs).
- Incomplete documentation: Thorough documentation of APQR findings, conclusions, and actions taken is essential for regulatory compliance and continuous improvement. However, using multiple systems, spreadsheets, and paper can make it difficult to get a complete picture of what is available or missing for product quality reviews, compromising data integrity.
How to Optimize Your APQRs
The key to avoiding the pitfalls of APQRs is to reduce the manual and paper-based tasks associated with APQR. This can be done by using a digital system that brings together APQR data from different sources, allows process monitoring, and creates real-time reporting.
We recommend ValGenesis Process Insight as the most effective platform for monitoring, analyzing, comparing, and managing the lifecycle of the manufacturing processes.
Automated Monitoring
The first step in optimizing your APQRs focuses on monitoring critical process parameters (CPPs) and critical quality attributes (CQAs) in real time or near real time during manufacturing.
ValGenesis Process Insight aggregates information from multiple data sources and observes real-time batch trends per process variable, correlating the process parameters and the quality attributes within 10 seconds.
This allows manufacturers to overcome the challenge of inadequate data collection while making data collection continuous rather than relying on periodic data collection. Reliable and continuous data will allow manufacturers to detect deviations from established norms or trends that may indicate potential quality issues sooner, minimizing the impact on product quality.
Advanced Analysis
ValGenesis Process Insight aggregates all this data, dismissing the need for separate files in separate locations. Product data is centralized with an end-to-end view, which supports continuous process improvement, root cause analysis, and any necessary corrective and preventive actions.
But more than that, ValGenesis Process Insight performs multivariate data analysis, using statistical and multivariate techniques to analyze complex datasets of multiple process parameters. These analyses help identify correlations, trends, and patterns in the data, enabling better process understanding and control.
Last but not least, the knowledge obtained from these advanced analyses may support the identification of opportunities for process optimization and quality improvement, which can be addressed in the APQR.
Enhanced Documentation
ValGenesis Process Insight generates detailed reports and data logs, which can be used as documentation for the APQR. These reports provide evidence of process performance, deviations, corrective actions taken, and any other relevant information required for regulatory compliance. They can be fully automated, removing potential human errors from the process.
The primary benefit here is facilitated regulatory compliance. By having comprehensive and well-documented data from Process Insight’s process monitoring capabilities, manufacturers can streamline the APQR process and ensure compliance with regulatory requirements. This proactive approach to quality management can yield positive results toward regulatory expectations during inspections and audits.
ValGenesis Process Insight is the Best Tool for Connected and Automated APQRs
ValGenesis Process Insight enables users to gather real-time data, detect issues early, analyze data effectively, improve process understanding, document findings comprehensively, and ensure regulatory compliance — all of which are essential for performing a thorough and effective APQR. Using it is a step forward in building comprehensive reviews of historical data to assess long-term process performance and identify opportunities for improvement.
