OSD
In pharmaceutical manufacturing, every deviation, out-of-specification (OOS) result, or equipment change costs precious time, money, and resources. Traditional problem-solving methods designed to prevent quality issues or to streamline changeover downtime often rely on trial-and-error experimentation, manual data reviews, or incomplete statistical analyses. These are inefficient and prone to human error, as they depend on the subjective interpretation of data and the expertise of individual personnel. Further, such an approach bears the risk of overlooking critical correlations as not all data may have been analysed.
The value of interconnected intelligence
ReciPredict offers the opportunity to address these challenges as it is a platform that uses statistical modeling and simulation to facilitate quality by design (QbD) in product development, tech transfer, and drug product manufacture. It allows data-driven decisions by applying data science and digital technology to develop and manufacture drug products, promising to deliver unparalleled efficiency and reliability.
ReciPredict helps address daily pharmaceutical manufacturing challenges by enabling informed decisions through the application of data science and digital technology to quality control and predictive maintenance.
Below are four key ways ReciPredict increases operational performance by prediction:
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Speed up OOS investigations and root cause analysis
OOS results — those that fall outside the predetermined acceptance criteria and quality standards — are among the most challenging issues in pharmaceutical manufacturing. Identifying the root cause often requires combing through large volumes of data—process parameters, raw material attributes, machine settings, environmental conditions, and more. Failure to identify OOS products during manufacturing — or to prevent them occurring in the first place — is not just wasteful and costly, but can have ramifications for patient safety and regulatory compliance.
ReciPredict can help overcome this issue in many ways:
- Comprehensive data correlation: ReciPredict consolidates and correlates all relevant process data, such as temperature and pressure readings, as well as humidity levels, in one statistical model, pinpointing which variables most likely contributed to the OOS.- Automated insights: Instead of manual data review, ReciPredict uses algorithms to quickly reveal hidden relationships, enabling manufacturers to narrow down the potential causes faster, with less risk of human error.
- Effective corrective actions: Once a root cause is identified, ReciPredict can build a related model and can suggest the most impactful variables to address, helping teams implement more effective corrective and preventive actions (CAPAs).
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Predict and prevent deviations before they affect quality
Manufacturing deviations cause issues for manufacturers. Small parameter shifts and process anomalies can not only affect product quality, they can also increase the risk of waste. Expensive raw ingredients might be over-used during production, increasing costs unnecessarily. Time-consuming additional testing may be needed, with the potential for entire batches to be discarded, significantly impacting the drug product supply chain.ReciPredict removes the error from trial and error around deviation prevention by allowing production line operatives to:
- Learn from the past: ReciPredict uses existing data to understand how past deviations have impacted final product quality attributes. This allows manufacturers to predict the outcome of current deviations, so they can prioritise corrective actions.- Receive early warnings: The models can flag at-risk batches or processes early, allowing operatives to take timely action before a significant deviation occurs.
- Quantify quality risks: By linking any given deviation to its historical impact on product attributes, ReciPredict offers a numerical or statistical view of potential quality outcomes.
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Streamline process improvement and equipment transfer
Continuous improvement is integral in pharmaceutical manufacturing. However, pinpointing the most impactful changes and proving process capability can be a slow, trial-heavy approach. Moreover, scaling up or transferring a process to new equipment can involve numerous rounds of experimentation.
ReciPredict can streamline improvement processes through quality by design, simplified:
- Reduce process variability: ReciPredict’s statistical models show where variability arises—be it from raw materials, machine settings, or operator practices. By highlighting key drivers of variability, you can systematically focus to reduce variability.
- Improve process robustness: By quantifying each variable’s influence on critical quality attributes, ReciPredict allows the fine-tuning of process parameters to reduce variability, improve batch consistency, and ultimately achieve a higher process capability index (Cpk). -
Acceleration of equipment transfers and scale-ups
Scaling up or transferring to a “non-like” piece of equipment often requires multiple pilot runs, which can cost time, energy and raw material.
By creating mathematical models grounded in historical data, ReciPredict predicts how a process will behave at a new scale or on different equipment—with fewer experimental trials. The result is:
- Less waste: Fewer trials reduce the consumption of costly materials.
- Faster time-to-market: Fewer experimental runs mean projects move faster.
- Improved reliability: Data-driven insights mitigate risks and uncertainties associated with scale-up or technology transfer.
Interconnected intelligence enables data-driven decisions
From quickly identifying the causes of OOS results and quantifying the impacts of deviations to honing in on the most critical process parameters and enabling smoother equipment transfers, ReciPredict empowers pharmaceutical manufacturers to make data-driven decisions. This not only speeds up problem-solving but also drives ongoing improvements, better process capability, and higher-quality products—crucial advantages in a tightly regulated environment.
To find out more about how ReciPredict can support your business, contact our experts.