Quality by Design
OctoPlus fully implemented Quality by Design (QbD) methodology
Are your drug development projects suffering from cost over-runs and unproductive delays? QbD is the answer. OctoPlus has implemented QbD methology and therefore partnering with OctoPlus means decreasing development budget and ensuring robust processes.
Most companies still use the traditional development process which is an experimental approach to determine quality by continuous testing of finished products. The disadvantage of this approach is that it does not take into account the variability of the process and material controls. QbD ensures quality by having a thorough understanding of all different components and processes involved in every stage of the drug development. In other words, QbD is not limited to finished product testing as it is continuously monitoring the process and ensures the most efficient and focused in-line analysis and quality control. Quality issues can always be efficiently analyzed and its root cause quickly identified.
The benefits of QbD
- Cost and time effective
- Ability to meet regulatory expectations so ensuring a smooth product approval
QbD is advised by the regulatory agencies: EMA, FDA and ICH.
OctoPlus makes use of several advanced Statistical tools
Design of Experiments (DoE)
- Speed up the setup of the processes and increase the throughput
- Reduce expensive product material and labor complexity
- Minimize process variation and reduce waste (rework & scrap) and the need for routine quality inspection
- From classical multivariate analysis to Bayesian network (BN), Artificial Neural Network (ANN) and Monte Carlo Simulation.
Real-Time Statistical Process control (SPC):
- Reduce costs and identify deviations in Real-Time
- Promptly react to process changes
- Make real-time decisions
- Other statistical tools are Robustness by Design and our proprietary OctoDesign
OctoPlus believes in Good Science : “Do the right thing, the right way, at the right time”
We use Fractal mathematics which is a tool for the analysis of the product at different stages of the production process by using Micro-imaging techniques.
Risk-Assessment is an integral part of OctoPlus’ way of working
OctoPlus uses Multiple Failure Mode and Effects Analysis (FMEA).