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Pharma Quality by Design (QbD)

Quality by Design is a scientific, risk-based holistic and proactive approach to pharmaceutical development with customer (common man) requirements in focus. It is a deliberate design effort from product conception through commercialization. Quality by Design is build on customer/ patient or a common man wants and needs and aims to deliver a product, a process or a output that meets those needs. The concepts and guidance determined by The International Conference on Harmonisation (ICH Guideline documents such as Q8, Q9, Q10) is of great value using Good practices and sound science to assure fit for intended use quality and sufficient product safety throughout the entire life cycle. SSA in addition to many segments has been consulting many pharma companies as well. SSA has been a pioneer in the field of quality in India and has helped hundreds of organizations imbibe quality in their products and processes worldwide. Taking into account the pressing need of pharmaceutical industry, SSA is offering this program for Implementation of Quality by Design. The program covers all the statistical tools and analytical techniques required for QbD framework. These include, among other things, application knowledge of: Statistics, Risk Assessment, and Design of Experiment.

  • Building Quality into the Product and Process and reduce reliance on testing of Quality.
Target Audience:
  • Everyone involved in Drug Development
QbD Approach:
  • Techniques to identify the Critical Quality attributes of the drug.
  • Application of techniques like C&E and FMEA to effectively perform risk assessment and identify the significant process parameters and material attributes.
  • Statistical techniques like MSA, ANOVA etc. to effectively carry out DOE.
  • Application of DOE with Response Surface Methodology to develop the Design space and optimize it.
  • Application of Monte Carlo Simulation to set up the tolerances in the Design space.
  • Techniques for effective scale up for manufacturing process.
  • Application of Process Analytical Technology to effectively control the manufacturing Process.
  • Robust product and processes
  • Reduce Production losses
  • Reduce deviations and recalls
  • Training provided by experts from the pharmaceutical industry.
  • Rich experience of consulting and training in pharmaceutical industry
  • Experienced faculties to help you understand Design of Experiments