Quality by Design


Pharmaceutical “Quality by Design” (QbD): An Introduction, Process Development and Applications

  • Begin with a target product profile that describes the use, safety and efficacy of the product
  • Define a target product quality profile that will be used by formulators and process engineers as a quantitative surrogate for aspects of clinical safety and efficacy during product development
  • Gather relevant prior knowledge about the drug substance, potential excipients and process operations into a knowledge space. Use risk assessment to prioritize knowledge gaps for further investigation
  • Design a formulation and identify the critical material (quality) attributes of the final product that must be controlled to meet the target product quality profile.
  • Design a manufacturing process to produce a final product having these critical material attributes.
  • Identify the critical process parameters and input (raw) material attributes that must be controlled to achieve these critical material attributes of the final product. Use risk assessment to prioritize process parameters and material attributes for experimental verification. Combine prior knowledge with experiments to establish a design space or other representation of process understanding.
  • Establish a control strategy for the entire process that may include input material controls, process controls and monitors, design spaces around individual or multiple unit operations, and/or final product tests. The control strategy should encompass expected changes in scale and can be guided by a risk assessment.
  • Continually monitor and update the process to assure consistent quality.

Design of experiments (DOE), risk assessment, and process analytical technology (PAT) are tools that may be used in the QbD process when appropriate. They are not check-box requirements.

Quality by End Product Testing

Quality by Design

SigmaTech 3.1   


SigmaTech 3.1  is a software for achieving objectives of QbD. It is useful for Designing and building quality into the process using DOE technique.


The statistically planned experimental data will be analysed by this software to build the statistical/mathematical model and provide various simulation techniques for optimal design of the process.  This software is useful for applications in Research & Development of API(active pharmaceutical ingredients), Pharmaceutical formulations, Biotechnology Process, Contract Research work, Chemical Process and Analytical Research work.


  • Some of the salient features of this software are:
  • Helps in screening for the vital few variables
  • Helps in Robust Process design with cost optimized
  • Helps in process validation
  • Enables Six Sigma Process development
  • Regulatory compliance with 21 CFR part 11
  • Screens cost effective alternative materials
  • Identifies the key factors affecting a process consistency
  • Balances multiple output characteristics to achieve desirable out comes
  • Significantly reduces the rejections to improve the bottom line of an organization