A subsidiary of
Dr. Reddy's Laboratories Ltd.

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

  • Quality
  • 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).

OctoPlus develops complex injectable formulations

Do you have a drug product that needs to be turned into an injectable pharmaceutical product?

Do you need an innovative approach for solving the challenges related to your complex drug development?

Partner with OctoPlus!

More information

Vision & Mission

Our vision is, either independently or in collaboration, joining forces with the academic world and industry, to make innovative injectables available to a global market. Good health can't wait.

 

Our mission is to accelerate access to affordable and innovative injectables

Contact us

Meet OctoPlus at

Controlled Release Society
26-Jul-15 - 29-Jul-15 

Edinburgh

BIO International Convention
15-Jun-15 - 18-Jun-15
Philadelphia, PA

AAPS Annual Meeting
25-Oct-15 - 29-Oct-15
Orlando, FL
 
BioEurope
2-Nov-15 - 4-Nov-15
Munich

More events

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