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:
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.
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:
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.
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.
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.
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 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.