SMIMA1091U Quality by Design (QbD) in Pharmaceutical Development

Volume 2015/2016
Education

Master's Programme in Industrial Drug Development - elective

The course is intended as continuing professional development (CPD) for professionals in the pharmaceutical industry, particularly in production, regulatory affairs and quality functions. The course will be an excellent introduction for those less familiar with QbD and will provide those with more experience on QbD with new ideas on how to further implement the company’s QbD programme.

The course is preapproved as an elective in the Master of Industrial Drug Development (MIND) programme, the Master of Pharmaceutical Regulatory Affairs (MPRA) programme and Master of Drug Management (MDM) programme and open for freelance students who meet the admission criteria. Students who gain admission to courses will receive an invoice and an admission letter.

Content

Quality by Design (QbD) is at the very heart of modern pharmaceutical development. The implementation of QbD principles provides cost-efficient approach for delivering high quality medicines for patients. Regulatory authorities - both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) - are placing great emphasis on the QbD component as a part of regulatory filing. QbD has become a crucial element of a stream-lined drug development process.

This course will provide an insight into the key principles of QbD covering quality risk management, formal experimental design and process analytical technology (PAT). Leading QbD experts – from industry, regulatory and academic side – will introduce the current knowledge on QbD and provide participants with ideas how this knowledge can be implemented in your company. The course includes practical demonstrations.
 

The course will provide a thorough introduction to the underlying principles and tools required for QbD-based pharmaceutical development and manufacturing:

  • Basic risk analysis techniques
  • Constructing the quality target product profile (QTPP)
  • Identification of critical quality attributes (CQAs) and critical process parameters (CPPs)
  • Design of Experiments (DoE): Basic screening designs, expanded designs
  • Process Analytical Technologies (PAT): basic principles of chemometrics, purpose of process measurements in pharmaceutical development and manufacturing, examples of process measurement techniques
  • Risk based regulatory framework.
Learning Outcome

After completing the course the student must have gained the following knowledge, skills and competencies:

Knowledge

  • summarize the principles of the QbD approach in pharmaceutical development and manufacturing
  • demonstrate basic knowledge about risk management, design of experiments and PAT
  • demonstrate basic knowledge about the relationship of the QbD approach into design space and further, into the regulatory framework


Skills

  • apply basic risk analysis and design of experiments techniques into practical cases

  • identify and suggest suitable process analytical tools for a given manufacturing environment

Competencies

  • work in a multidisciplinary risk management team
  • plan and implement basic design of experiments (DoE) approach

  • suggest a QbD approach for constructing a design space.

Literature

The common course syllabus is a collection of legislation, presentations (hand-outs) and cases, approx. 300 pages.

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English
The course is organized as an intensive 5-day course and comprises lectures, group discussions, presentations and discussions. In order to emphasize the flow of the process, the course is to a large extent based on the use of cases in both lectures and assignments.
  • Category
  • Hours
  • Class Instruction
  • 40
  • Exam
  • 20
  • Preparation
  • 22,5
  • Total
  • 82,5
Credit
3 ECTS
Type of assessment
Written assignment
An essay based on a selected QbD case and the common course syllabus. The essay must be 8-15 pages.
Exam registration requirements

Active participation in the course is a prerequisite for assessment.

Marking scale
passed/not passed
Censorship form
No external censorship
Exam period

Deadline for submission of written report: before 6 october 2015 at 16:00.

Re-exam

6 November 2015.

Criteria for exam assesment

To pass the exam, the participant must have:

  • Written a comprehensive and structured report on a selected case in his/hers own words, which is based on relevant literature.
  • Demonstrated an ability to find, understand and report relevant literature for the selected case.
  • Demonstrated knowledge of the principles and terms used in the field of QbD in pharmaceutical development.
  • Demonstrated an understanding of the central concepts and disciplines relevant for the selected case.