Quality by Design in Pharmaceutical Development

A 3-day course in collaboration with Paul Murray Catalysis Consulting Ltd.

Date: 04 March - 06 March 2020

Location: Clearwater, USA

Tutors: Dr Paul Murray

QbD is an industry initiative supported by regulators. However, it is also a systematic method of process development which delivers consistency, robustness and increased process knowledge.

This course introduces QbD across all areas of pharmaceutical development including synthesis, formulation and analysis, and suggests practical recommendations for the implementation of QbD.

Participants will learn how to identify and prioritise process parameters, determine and manage risk, and implement control strategies. The use of experimental design (DoE) in QbD, the identification of potential mixing and scale-up problems, and the safe scale up of processes to pilot and manufacturing plants will also be discussed.

For the benefit of process scientists, engineers, formulators, analytical chemists and manufacturing personnel, this course includes highly interactive, hands-on workshops, based on several case studies.

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Course Content

    • Introduction: Why QbD, what is QbD? FDA objectives, the QbD approach
    • The QbD process: QTPP, assessing risk, working through unit operations to determine CPPs and CMAs
    • QbD in chemical development, formulation, method development, and manufacturing
    • Drug properties: setting your QTPP, risk assessment, risk management, risk assessment questions
    • Identifying CQAs: drug product QAs, drug substance QAs, raw material QAs
    • Determining CPPs and CMAs
    • Product or Process design
    • Criticality: of PP and MA, CPPs and scale dependence
    • Consideration of impurities, ICH M7 and QbD, control strategies, case study
    • Control strategies: different levels, monitoring and control, post-approval changes
    • Chemistry and scale up considerations: process complexity, mixing, mass transfer, heat transfer, modelling
    • Process capability, process analytical technology
    • QbD and continuous processing: FDA perspective, advantages, challenges
    • Quantification of CPPs
    • DoE in QbD: introduction to DoE, where does DoE fit in QbD
    • QbD in API manufacture, case studies
    • QbD in Action: breakout workshop and case studies
    • Initial expectations vs current practices
    • Summary and definitions

Course Objectives

  • To provide a comprehensive understanding of QbD including current uses and promised use
  • To provide a step-by-step process for successful QbD
  • To introduce DoE for QbD purposes
  • To apply QbD to develop safe and robust processes
  • To use a comprehensive manual with examples and case studies to further educate on the QbD process

After completing the course attendees should have:

  • A comprehensive understanding of QbD including the process and all associated definitions
  • The ability to develop and use Quality Target Product profiles (including identifying CQAs, identifying, prioritising and quantifying process parameters and material attributes)
  • An understanding of different risk assessment techniques to determine and manage risk
  • Ways to determine and implement control strategies
  • The skills required to develop and understand the robustness of processes
  • The tools to identify potential mixing and scale up problems
  • An understanding of DoE in relation to QbD
  • An appreciation of the benefits of continuous manufacturing from a QbD perspective
  • An appreciation of QbD in analytical chemistry, formulation, process development and manufacturing
  • An appreciation of PAT in QbD

Who Should Attend

Chemists, engineers, analysts and formulators in pharmaceutical development

Anyone involved with the development of new or existing drug products; changes or improvements to existing or generic drugs are subject to QbD principals.

What's Included

The course fee includes:

  • comprehensive course manual
  • coffee/tea refreshments breaks throughout each day
  • buffet lunch each day
  • course dinner on the first evening
  • course certificate