Smart quality tools: Enabling real-time medicine quality monitoring and decision-making
For many decades, medicines have been produced using batch manufacturing techniques in which multiple unit operations are conducted and tested in silos before arriving at a final product. This is a cumbersome and time-consuming activity requiring numerous handshakes or handovers and is prone to human errors. Therefore, regulators are promoting the adoption of modern digital tools and technologies in transitioning the drug industry from batch manufacturing to continuous manufacturing.
Intelligent tools for continuous manufacturing
The recent pandemic has further fuelled the need to quickly adopt digital tools to ensure seamless production of medicines to avoid drug shortages. In continuous manufacturing, the highest level of integration and automation is required to create a non-stop flow of medicines from the manufacturing sites. This entails real-time monitoring of quality attributes of medicines under production. In 2019, USFDA published a draft guidance titled Quality Considerations for Continuous Manufacturing, elaborating on the various aspects contributing to product quality. The guideline specifically emphasizes - For real time process monitoring and decision-making to be feasible, the integrated equipment and control strategy requires a robust automated platform to orchestrate production. By promoting the adoption of automated tools in pharma manufacturing, FDA is trying to enhance the data integrity and reliability to safeguard public health. Therefore, smart quality tools based on modern technologies like golden batch intelligence and unplanned deviation intelligence can boost continuous manufacturing practices.
Achieving operational efficiencies and quality control
Golden batch intelligence will continuously monitor the compliance of process parameters (critical and non-critical) with golden batch or standard reference batch parameters. This ensures adherence to design space and provides real-time alerts to production chemists if any potential aberrations from the target process specifications are identified. Accordingly, the production user can exercise the necessary process controls to preserve the quality of the medicines under manufacturing.
Similarly, unplanned deviations can stop the continuous or batch manufacturing processes. While planned deviations are addressed well in advance through a formal risk-assessment process, unplanned deviations can pause the production activities. This unexpected production hold-time will affect production efficiency and deteriorate the quality of in-process materials or products. The Smart quality unplanned deviation intelligence (DevI) tool enables the user to react to unexpected deviations by quickly identifying the root cause by fetching identical deviation data from various manufacturing sites. The tool also provides ready-to-fill templates like root cause analysis, investigation plan and corrective and preventive actions to close the unplanned deviation and quickly resume the manufacturing operations.
Smart quality tools provide multiple benefits:
- Manufacturers benefit from enhanced production and efficiency.
- Regulators benefit from accelerated regulatory reviews due to the high accuracy and integrity of production data.
- Patients benefit from the timely availability of quality, safe and efficacious medicines.
You can optimize your manufacturing processes and improve quality and operational efficiencies.
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