Faculty of Pharmacy and Pharmaceutical Sciences

Monash University

Undergraduate - Unit

This unit entry is for students who completed this unit in 2013 only. For students planning to study the unit, please refer to the unit indexes in the the current edition of the Handbook. If you have any queries contact the managing faculty for your course or area of study.

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6 points, SCA Band 2, 0.125 EFTSL

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FacultyFaculty of Pharmacy and Pharmaceutical Sciences
OfferedParkville Second semester 2013 (Day)
Coordinator(s)Dr Laurence Orlando


This unit will be run with a problem based learning approach with a project of developing a pharmaceutical form from the initial powder to the production of the final form.

Students will develop an understanding of:

  • product development
  • design of experiments
  • powders type of processing (milling, mixing, handling)
  • fundamental and derived properties of solid powders
  • manufacture of pharmaceutical forms (tablets BFS spray drying)
  • GMP, GLP and quality assurance,
  • project management
  • design of a manufacturing plant
  • intellectual property

The unit also includes an Industry Week where students visit various industries in covering a range of activities related to their studiesthe curriculum, for students to gain an appreciation of how the product development process is conducted in a real world situation. They will also and discover understand the range of industrial activities that they will be able to apply for in the future as well as distinguish various specific aspects or requirements for each industry. In complement, students will also be exposed to "career start" sessions where the notions of interview, CV and career planning will be addressed to accompany the activities in Industry week.


At the end of this unit students will be able to:

  1. Describe the various stages in Drug Product Development and production;
  2. Discuss the important aspects of quality assurance and how QA is applied in product development and manufacturing processes;
  3. Understand the importance of Design of Experiments (DoE) in the ICH and Quality bBy Design (QbD) context in each stages of product development;
  4. Understand and manipulate high level complex Excel functions to produce an automatic calculation programs;
  5. Apply these functions to elaborate a DoE program to automatically run Plackett Burman screening DoEs and factorial plans that can be applied in the problem cases encountered in the context of this unit, and ultimately in their future professional activity;
  6. Discuss the industrial context and purpose for, as well as the basic theory of processes for: particle size reduction, powder blending, material drying, material handling and transport;
  7. Have a basic appreciation of fine powder behaviour and characteristics, and material properties influencing formulation;
  8. Understand the principles of designing manufacturing plants and compile the knowledge to design the blueprint of an efficient pharmaceutical manufacturing plant
  9. Apply the principles of project management to run the project;
  10. Describe terminology and basic concepts around intellectual property
  11. Identify areas of interest for their future career;
  12. Prepare for job applications by producing a CV and developing interview skills.


Final exam (2 hours): 60%; written assessments: 40%.

Chief examiner(s)

Contact hours

Contact hours for on-campus students:
Twenty 2-hour lectures
Twenty 2-hour workshops
Industry week: twenty eight hours

Additional information on this unit is available from the faculty at: