In pharmaceutical quality control, the dominant paradigm has long been the reliance on end product testing for ensuring the safety, efficacy, and quality of drug products. In this blog post, I will briefly outline real time release, a new model that has emerged to challenge the established approach, and what this means for both Quality teams and for Binocs as a resource planning and scheduling system in QC labs.
In a rush? Here are the 3 key takeaways
👉 “Real time release” is a relatively new testing paradigm that relies on monitoring the quality of raw mats and intermediates during the manufacturing process to expedite the release process and improve operational efficiency
👉 RTR will not replace end product testing because this is still required to ensure final product safety and effectiveness, however a hybrid model combining both will reduce the need lengthy analysis in the QC lab
👉 The resource planning and scheduling tools like Binocs that QC teams already use will continue to be important in a hybrid testing model as they will help teams to navigate the increased complexity
End product testing
End Product Testing (EPT) has been the gold standard in pharmaceutical QC for decades. It typically involves batch manufacturing, whereby samples of the product are collected at the end of the production process. Before the product can be released to market, the samples must be subjected to a battery of different tests to measure a wide range of quality attributes and compare these with expected results. These can include chemical analysis, physical characterization, microbiological testing, and other specific assessments.
This approach provides an holistic evaluation of the product’s quality and ensures compliance with regulatory requirements, however, it also can also contribute significantly to the end-to-end product release lead time, potentially delaying patient access to the drugs. This is because EPT operates on the assumption that thorough (and sometimes lengthy) testing at the end of the manufacturing process is necessary to guarantee product safety and efficacy; however, in recent years, a new paradigm has emerged that challenges this assumption.
Real time release
Real time release (RTR) represents a departure from the traditional EPT model. Instead of relying solely on end product testing, RTR incorporates in-process control testing (IPCT) and continuous monitoring of critical quality attributes and key process parameters throughout the manufacturing process. The quality of the raw materials and intermediates is tested in real time at different points in production, often using advanced analytical techniques and technologies.
There are three main advantages to implementing RTR:
It reduces release time by eliminating the need for extensive end product testing, ensuring faster availability of drugs to patients;
It enhances process understanding and control, optimizing manufacturing processes and improving product quality.
It enables early detection of process deviations, allowing prompt corrective actions to maintain product quality.
By reducing the reliance on end product testing, RTR allows for proactive control and intervention to maintain product quality, and aims to expedite the release process and improve operational efficiency.
Will RTR replace EPT?
Despite its advantages, it is important to emphasize that RTR reduces reliance on extensive EPT. Testing the final product remains a critical component of quality assurance, providing a comprehensive assessment of the effectiveness and safety of the actual drug that will be used by patients. In addition, many products have highly complex attributes that are challenging (or even unfeasible) to measure accurately or reliably in real time. Furthermore, EPT is a long-standing practice in the pharmaceutical industry, with established methodologies and extensive historical data that provide reliable and repeatable benchmarks, which is also why it is embedded in the guidelines and requirements of the various regulatory agencies.
Rather than replacing it, RTR should be viewed as a complementary approach that can be implemented in combination with EPT as part of a new, hybrid model of testing. This would offer the best of both worlds, leveraging in-process testing for efficiency while ensuring comprehensive product evaluation through end product testing (albeit with a reduction in the volume of required analytical tests).
Challenges for Quality teams
A hybrid approach will, however, present some challenges for QC teams:
Analysts will need to adapt to new processes and environments to accommodate a greater use of IPCT and in-line monitoring on the production floor;
There will also be a greater scope of methods and techniques, some of which will be more advanced than traditional QC processes and which will therefore require additional training;
By combining the two paradigms, already-complex QC processes could become even more complicated, both in terms of methodological requirements but also planning and coordination, and communication with other stakeholders in the end-to-end flow;
There may also be an enhanced regulatory burden, as QC teams will be required to understand and comply with the requirements for two distinct methodologies.
The role of Binocs
Far from signaling an end to the benefits of using a tool like Binocs, the increased use of RTR processes by QC teams will present new reasons to implement an effective resource planning and scheduling solution.
As outlined, a hybrid model will increase operational complexity for Quality departments, thus making the enhancements offered by Binocs all-the-more valuable. Resource utilization optimization, task prioritization, and capacity planning all apply equally to in-line processes as they do batch testing. Similarly, being able to accurately visualize workflows and report on KPIs is critical to effective real time monitoring, while being able to integrate directly with other systems such as an MRP and QMS (in addition to LIMS) will help to streamline and automate certain processes.
Real-time release represents an exciting advancement in pharmaceutical quality control, offering faster release times, enhanced process understanding, and early detection of deviations. While RTR is unlikely to replace end product testing entirely, a hybrid model combining both approaches is expected to prevail. QC teams can leverage a resource management tool like Binocs to navigate the complexities of the hybrid model effectively, optimizing resource allocation, streamlining schedules, and improving overall efficiency. As pharmaceutical QC continues to evolve, the role of tried and tested tools becomes increasingly valuable in ensuring high-quality and timely release of drug products, meaning that you’ll be seeing more (not less) of Binocs in QC labs in 10 years time!
Interested to learn more about Binocs for QC labs and QA functions? Why not reach out for a chat today?!
Adam has two decades of experience working in clinical trials, biomedical research, public health, and health economics, with a particular interest in the intersection between technology and life sciences. For 7 years before joining Bluecrux in 2019, Adam was the director of healthcare innovation consultancy “LeLan” and brings a wide range of insights to his role as Content Specialist for Binocs.