Quality assurance (QA) and quality control (QC) workflows play a vital role in pharmaceutical manufacturing chains, guaranteeing the safety and effectiveness of products that are ultimately administered to patients. These workflows must be both robust and efficient to ensure compliance with regulatory guidelines while, at the same time, delivering value for businesses.
When QA/QC issues arise, it’s essential that pharmaceutical and biotech companies can identify precisely where, when and why they occurred, and which batches were affected.
However, given the complexity of modern production lines, tracing the source and extent of problems can be a resource-intensive and time-consuming operation. The value chain for many pharmaceutical products involves a complex web of global production facilities, raw material suppliers and a distribution infrastructure with multiple stakeholders being responsible for individual steps.
Moreover, the volume of data these workflows produce can be overwhelming. From raw material procurement through product manufacture and testing to packaging and batch release, manufacturing chains generate a large amount of diverse information that can make searching for specific audit trail events as challenging as looking for a needle in a haystack.
To achieve full visibility of their production processes and to easily track and trace products, raw materials and QA/QC samples, many pharmaceutical organisations are turning to the latest integrated informatics solutions.
In this article, we look at how laboratory information management systems (LIMS) are helping businesses to connect their workflows, boost operational efficiency, improve regulatory compliance and, ultimately, deliver high quality products quickly and affordably.
Driving faster, more informed decisions
Pharmaceutical companies have a responsibility to protect public health by delivering safe and effective products … without exception.
To achieve this, drug manufacturing chains must be supported by accurate record keeping, robust data management and transparent audit trails. The need for clear and precise record keeping across the entire manufacturing chain means that many businesses are looking in detail at how they track their products and data.
Products should be traceable through every step, and each stakeholder in the value chain must be aware of the overall workflow in real-time. For instance, for each product batch, distribution must be informed that the product was approved by the QA/QC laboratory to successfully release the product to market.
If this is achieved, ensuring accountability becomes significantly easier. By contrast, if organisations have poor internal communication and batches are not properly tracked, there is a substantial risk of failed products reaching distribution. Poor batch release decisions could result in ineffective or even unsafe products being administered to patients, putting brand integrity and, potentially, public health at risk.
Many manufacturing chains still use paper documentation or manual workflows for some or all of their QA/QC processes. However, these systems leave workflows vulnerable to incorrect execution and the omission of key steps, as well as inconsistent and inefficient updates to standard operating procedures (SOPs).
Replacing paper-based approaches with digital systems can significantly improve how processes are executed and data is recorded. Storing electronic SOPs centrally in a LIMS gives users rapid access to the protocols and parameters they need to perform QA/QC analyses correctly and consistently.
LIMS simplify process development, execution and adherence, avoiding the pitfalls associated with paper records. By guiding users stepwise through SOPs and automating processes, these platforms can help businesses to reduce errors and achieve quality outcomes.
Furthermore, by integrating with instruments, LIMS enable all actions to be automatically recorded — and even allow workflows to be run remotely from anywhere at any time.
Another common source of inefficiency in QA/QC workflows is deteriorating instrument performance. Regular use of equipment can lead to a gradual decline in measurement quality without the user becoming aware of any performance issues.
By connecting all instruments and recording data in a single comprehensive platform, LIMS can be used to identify potential issues sooner, allowing corrective action to be taken before they result in more serious consequences. This type of integrated approach allows users to monitor and trend data associated with product quality or throughput for performance comparisons, and develop best practices for overall organisational efficiency and better decision making.
Connecting pharmaceutical production processes
When optimising pharmaceutical manufacturing workflows, the focus often tends to be on the part of the chain involving production, QA/QC testing and product release.
In reality, however, the process starts well before manufacturing even begins. Raw materials, consumables and packaging must be sourced from reliable suppliers and then tested and validated before any production can happen.
Modern pharmaceutical supply networks have gone global, with manufacturing facilities located around the world and raw materials and consumables sourced from multiple regions. Because of this trend, processes have become more complex and an expanding number of players are involved.
When ordering and receiving materials from multiple suppliers, proof of quality and traceability is critical. However, vetting suppliers and the validation of materials must be streamlined if manufacturing chains are to function efficiently. Additionally, stock inventories must be carefully managed to ensure production does not grind to an unexpected halt.
Some pharmaceutical companies still rely on conventional paper-based systems to record information associated with suppliers, raw material testing and inventory.
Paper documentation requires manual entry and repetitive actions for each material. Furthermore, recording and filing this documentation takes time and limits accessibility as the burden of administration grows. These systems are impractical, error prone and inefficient … and make accessing data challenging.
The latest digital solutions make running an efficient pharmaceutical production line easier than ever. LIMS platforms can connect global suppliers and allow manufacturers to track materials before, during and after QA/QC testing.
This creates a transparent chain of custody for all goods used during production. Digital solutions such as these support continuous processing and are a very effective way of driving the highest levels of data integrity and product quality.
Moreover, these digital platforms enable purchasing departments and downstream users to automatically track and trend real-time usage through a system of checks and approvals as materials are registered and used. This guarantees inventory will remain at required levels, and only raw materials and consumables that meet quality tests can enter the production cycle.
Greater transparency and regulatory compliance
The need to safeguard public health and deliver high-quality products has always been a priority for regulatory authorities. However, with manufacturing chains growing increasingly complex, there has been an enhanced focus on ensuring processes are compliant with the highest standards of data integrity.
In an effort to maintain the accuracy, consistency and completeness of data associated with pharmaceutical manufacturing chains, regulators are not only raising the bar when it comes to audit expectations, they are also encouraging organisations to put in place preventive measures to eliminate issues before they turn into larger problems. Given this new regulatory focus, workflow transparency and product traceability are becoming increasingly important.
Consequently, many drug manufacturers are assessing the tools they use to manage their workflows. QA/QC practices that employ disparate data systems, such as lab notebooks or paper-based records for process monitoring and execution, leave data vulnerable to human error and misinterpretation, and audit trails more susceptible to omissions.
Paper-based systems can lead to poor data management, meaning laboratories cannot demonstrate data quality, data integrity or traceability, and cannot keep up with increasingly stringent regulations. As a result, information recall for audit purposes, for example, can be time-consuming and inefficient.
The latest digital track and trace solutions are helping manufacturers to overcome these challenges. As therapeutic products move through successive phases of production, and batches are taken for QA/QC testing, the ability to track each product using a LIMS gives organisations the level of traceability they need to meet modern regulatory guidance around data integrity.
By joining the dots between processes and facilitating open communication between teams, labs can benefit from clear workflow transparency and product traceability across the entire manufacturing chain, facilitating easy audit trail generation and review.
The latest data management tools can help companies to simplify process development by integrating their workflows to achieve end-to-end oversight. LIMS platforms such as SampleManager, for example, bring together data, SOPs, instruments and processes to create a single connected system that spans the manufacturing pipeline.
This joined-up approach results in greater visibility and transparency around product movement and brings a higher level of organisation to each process. Because these modern solutions are completely integrated, searching for data is easier and records can be retrieved much more quickly.
In this way, LIMS can help pharmaceutical firms to use QA/QC data to pinpoint the sources of problems and take remedial action more quickly to ensure the highest standards of patient safety.
Conclusion
With the growing complexity of manufacturing operations and increased regulatory scrutiny, digital solutions can help businesses to achieve comprehensive oversight of their manufacturing workflows through robust track and trace functionality.
LIMS platforms bring together large volumes of data generated across every process in a pipeline to drive improvements, identify trends, streamline workflows and speed up decision making. As a result, these solutions are enhancing productivity and generating better quality outcomes across the pharmaceutical production line, ultimately helping manufacturers to deliver safe and effective products to patients in the shortest possible timeframe.