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Quality by Design (QBD) Guidance

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Pharmaceutical Quality by Design | QbD in India



Quality by Design is a scientific, risk-based holistic and proactive approach to pharmaceutical development with customer’s (common man) requirements in focus. It is a deliberate design effort from product conception through commercialization. Quality by Design is built on customer’s/ patient’s or a common man’s 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.

Why SSA?

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. The program features with industry specialists and experts facilitating quality implementation in various industries.

QBD implementation can give manufacturers much more confidence in the robustness of their product, potentially increases the efficiency and quality of their development and manufacturing process as well as reduces profit leakages.


  • Introduction
    • QbD in the context of the ICH guidelines for pharmaceutical manufacturing industry in the 21st century
    • QbD implementation ICH Guidelines
    • Real-time release

  • ICH Guidelines
    • Brief overview of ICH Q8, ICH Q9, ICH Q10 and ICH Q11
    • Risk-based, modern pharmaceutical manufacturing
  • Basics of statistics
    • Mean, Median, Mode
    • Variation and Standard Deviation
    • Descriptive statistics
    • Normal distribution, central limit theorem
    • Measurement System Analysis
  • QbD Methodology
    • The evolution of process understanding
    • Identification of critical quality attributes (CQAs) and critical process parameters CPPs
    • Process parameters ranking methods
  • Creating the Design space
    • Design space concepts and relevance of design space
    • Screening the Experimental Space
    • Identification of Key and Critical Process Parameters
    • Creating a factorial design
    • Analyzing a factorial design
    • Response surface methodology, process optimization
    • Using DoE to define a design space
    • Process validation in the QbD paradigm
  • Risk Analysis
    • Risk estimates
    • Process risk quantification
    • Control Plan
  • Scaling up
    • Scale-up theory; scaling-up by scaling-down
    • Process understanding for effective technology transfer
    • Advantages and challenges of continuous chemical processing
  • Process Analytical Technology (PAT)
    • PAT principles, levels of PAT implementation
    • Control strategies
    • Real time release

No. of days:  4 days (3.2 IACET CEUs)


  • Understand QbD approach for drug development
  • Design robust processes and assess key & critical process parameters
  • Construct a design space for drug development
  • Assess risk and apply risk control methods
  • Apply Process Analytical Techniques for continuous improvement


  • Analytical chemists
  • R&D chemists and chemical engineers
  • Process chemists & engineers, and formulators
  • Validation engineers
  • Quality assurance/compliance/control scientists
  • cGMP compliance scientists
  • Regulatory affairs personnel


  • Lecture
  • Chalk and talk approach
  • Group discussion
  • Case studies

The Following are the criteria for evaluation of the Participants:

  • Faculty assessment of the participants
  • Exam scores – minimum 70% to qualify.
  • Attendance to the training program

Upcoming Trainings


SSA is recognized as the first and only Authorized Provider in India of Continuing Education Units by the International Association for Continuing Education and Training (IACET). This puts SSA in the prestigious league of only 650 IACET CEU providers worldwide such as American Society for Quality (ASQ), Automotive Industries Action Group (AIAG), and Society of Automotive Engineers (SAE).

In-House Training Solutions


If you have a number of delegates with similar training needs, then you may wish to
consider having an In-House Training Solution delivered locally on-site.
Course can be tailored to specific requirements.

Please contact us on +91-9870064786 or email us on

Course Completion Certificate


Upon successful completion of the course, the participants will be given internationally recognized IACET certificates. SSA Training Solutions is one of the few only prestigious providers of the CEUs(Continuing Education Units) across the world.

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