PHARMACY 752 : Pharmaceutical Quality Assurance

Medical and Health Sciences

2021 Semester One (1213) (15 POINTS)

Course Prescription

Principles of good manufacturing practice (GMP), quality assurance and quality control as applied to pharmaceutical products and processes. Consideration of relevant industrial processes, legislation, safety issues, packaging, labelling, stability and regulatory requirements.

Course Overview

Pharmacy 752 is intended to provide you with the background and tools to apply the principles of quality assurance to the development, manufacturing, storage and distribution of pharmaceutical products.

Course Requirements

No pre-requisites or restrictions

Course Contacts

Course Director/Coordinator: Associate Professor Jingyuan Wen
 Email: Extn: 82762
HoD/Academic Director/ (Postgraduate-Taught): Associate Professor Jeff Harrison
 Email: Extn:82144

Capabilities Developed in this Course

Capability 1: Disciplinary Knowledge and Practice
Capability 2: Critical Thinking
Capability 3: Solution Seeking
Capability 6: Social and Environmental Responsibilities
Graduate Profile: Master of Health Sciences

Learning Outcomes

By the end of this course, students will be able to:
  1. Demonstrate an understanding of the various issues related to Quality Assurance and Good Manufacturing Practices (Capability 1.1 and 6.2)
  2. Understand and apply the procedures that help ensure the safety, efficacy, and quality of a product. (Capability 1.1 and 6.2)
  3. Understand and explain the role of the Quality Control and Quality Assurance in product development, manufacturing, storage, and distribution. (Capability 1.1, 2.2, 3.2 and 6.2)
  4. Describe and explain the concept and processes involved in a pharmaceutical analytical laboratory and Good Laboratory Practices. (Capability 1.1, 2.2 and 6.2)


Assessment Type Percentage Classification
Assignments 20% Individual Coursework
Coursework 40% Individual Coursework
Final Exam 40% Individual Examination
Assessment Type Learning Outcome Addressed
1 2 3 4
Final Exam

Workload Expectations

This course is a standard 15-point course and students are expected to spend 10 hours per week involved in each 15-point course that they are enrolled in.

For this course, you can expect 26-28 hours of lectures, 4-5 hours to meet with your supervisors for the special assignment, 70-75 hours to work on your course work and final exam.

Delivery Mode

Campus Experience

Attendance is required at scheduled activities including tutorials and industry visiting  to complete the components of the course.
Lectures will be available as recordings. Other learning activities including seminars, tutorials and industry visiting will not be available as recordings.
The course will include live online events including group discussions.
Attendance on campus is required for the oral presentation and exam.
The activities for the course are scheduled as a standard weekly timetable.

Student Feedback

At the end of every semester students will be invited to give feedback on the course and teaching through a tool called SET or Qualtrics. The lecturers and course co-ordinators will consider all feedback and respond with summaries and actions.

Your feedback helps teachers to improve the course and its delivery for future students.

Class Representatives in each class can take feedback to the department and faculty staff-student consultative committees.

Digital Resources

Course materials are made available in a learning and collaboration tool called Canvas which also includes reading lists and lecture recordings (where available).

Please remember that the recording of any class on a personal device requires the permission of the instructor.

Academic Integrity

The University of Auckland will not tolerate cheating, or assisting others to cheat, and views cheating in coursework as a serious academic offence. The work that a student submits for grading must be the student's own work, reflecting their learning. Where work from other sources is used, it must be properly acknowledged and referenced. This requirement also applies to sources on the internet. A student's assessed work may be reviewed against online source material using computerised detection mechanisms.

Inclusive Learning

All students are asked to discuss any impairment related requirements privately, face to face and/or in written form with the course coordinator, lecturer or tutor.

Student Disability Services also provides support for students with a wide range of impairments, both visible and invisible, to succeed and excel at the University. For more information and contact details, please visit the Student Disability Services’ website

Special Circumstances

If your ability to complete assessed coursework is affected by illness or other personal circumstances outside of your control, contact a member of teaching staff as soon as possible before the assessment is due.

If your personal circumstances significantly affect your performance, or preparation, for an exam or eligible written test, refer to the University’s aegrotat or compassionate consideration page

This should be done as soon as possible and no later than seven days after the affected test or exam date.

Learning Continuity

In the event of an unexpected disruption we undertake to maintain the continuity and standard of teaching and learning in all your courses throughout the year. If there are unexpected disruptions the University has contingency plans to ensure that access to your course continues and your assessment is fair, and not compromised. Some adjustments may need to be made in emergencies. You will be kept fully informed by your course co-ordinator, and if disruption occurs you should refer to the University Website for information about how to proceed.

Student Charter and Responsibilities

The Student Charter assumes and acknowledges that students are active participants in the learning process and that they have responsibilities to the institution and the international community of scholars. The University expects that students will act at all times in a way that demonstrates respect for the rights of other students and staff so that the learning environment is both safe and productive. For further information visit Student Charter


Elements of this outline may be subject to change. The latest information about the course will be available for enrolled students in Canvas.

In this course you may be asked to submit your coursework assessments digitally. The University reserves the right to conduct scheduled tests and examinations for this course online or through the use of computers or other electronic devices. Where tests or examinations are conducted online remote invigilation arrangements may be used. The final decision on the completion mode for a test or examination, and remote invigilation arrangements where applicable, will be advised to students at least 10 days prior to the scheduled date of the assessment, or in the case of an examination when the examination timetable is published.