BIOPRENG 4036 - Ensuring Quality in Pharmaceutical Manufacturing

North Terrace Campus - Semester 2 - 2024

The aim of this course is to introduce the strategy for producing high quality safe pharmaceutics. This module will focus on the traditional approaches to ensure product quality using facility design, validation and good manufacturing practice (GMP). The concepts of quality by design (QbD), process analytical technology (PAT) and continuous manufacturing will be introduced. Special reference will be made to the manufacture of biologics including antibiotics, therapeutic proteins and vaccines.

  • General Course Information
    Course Details
    Course Code BIOPRENG 4036
    Course Ensuring Quality in Pharmaceutical Manufacturing
    Coordinating Unit Bioprocess Engineering
    Term Semester 2
    Level Undergraduate
    Location/s North Terrace Campus
    Units 3
    Contact Up to 4 hours per week
    Available for Study Abroad and Exchange Y
    Course Description The aim of this course is to introduce the strategy for producing high quality safe pharmaceutics. This module will focus on the traditional approaches to ensure product quality using facility design, validation and good manufacturing practice (GMP). The concepts of quality by design (QbD), process analytical technology (PAT) and continuous manufacturing will be introduced. Special reference will be made to the manufacture of biologics including antibiotics, therapeutic proteins and vaccines.
    Course Staff

    Course Coordinator: Professor Robert Falconer

    Course Timetable

    The full timetable of all activities for this course can be accessed from Course Planner.

  • Learning Outcomes
    Course Learning Outcomes
    On successful completion of this course students will be able to:

    1 Understand the evolution of current regulation of pharmaceutical manufacturing
    2 Appreciate the role of the regulatory authorities (TGA, FDA, EMA, etc) in ensuring pharmaceutical products and medical devices are safe and efficacious.
    3 Know how to implement validation to a pharmaceutical manufacturing unit operation and to an analytical technique used to measure pharmaceutical product quality
    4 Know how to implement Good Manufacturing Practice to pharmaceutical manufacturing
    5 Understanding the basics of hygiene, cleaning-in-place in pharmaceutical operations
    6 Understanding of the design considerations for pharmaceutical manufacturing facility design
    7 Know how to source regulatory guidance documents from the ICH and FDA

    The above course learning outcomes are aligned with the Engineers Australia Stage 1 Competency Standard for the Professional Engineer.
    The course is designed to develop the following Elements of Competency: 1.1   1.3   1.4   1.5   1.6   2.1   2.2   2.3   2.4   3.1   3.2   3.3   3.4   3.6   

    University Graduate Attributes

    This course will provide students with an opportunity to develop the Graduate Attribute(s) specified below:

    University Graduate Attribute Course Learning Outcome(s)

    Attribute 1: Deep discipline knowledge and intellectual breadth

    Graduates have comprehensive knowledge and understanding of their subject area, the ability to engage with different traditions of thought, and the ability to apply their knowledge in practice including in multi-disciplinary or multi-professional contexts.


    Attribute 2: Creative and critical thinking, and problem solving

    Graduates are effective problems-solvers, able to apply critical, creative and evidence-based thinking to conceive innovative responses to future challenges.


    Attribute 3: Teamwork and communication skills

    Graduates convey ideas and information effectively to a range of audiences for a variety of purposes and contribute in a positive and collaborative manner to achieving common goals.


    Attribute 4: Professionalism and leadership readiness

    Graduates engage in professional behaviour and have the potential to be entrepreneurial and take leadership roles in their chosen occupations or careers and communities.


    Attribute 5: Intercultural and ethical competency

    Graduates are responsible and effective global citizens whose personal values and practices are consistent with their roles as responsible members of society.


    Attribute 8: Self-awareness and emotional intelligence

    Graduates are self-aware and reflective; they are flexible and resilient and have the capacity to accept and give constructive feedback; they act with integrity and take responsibility for their actions.

  • Learning Resources
    Recommended Resources
    Regulatory Guidelines

    International Conference on Harmonisation, November 1995, ICH Harmonisation Tripartite Guideline, Structure and Content of Clinical Study Reports, E3
    International Conference on Harmonisation, June 1996, ICH Harmonisation Tripartite Guideline, Guideline for Good Manufacturing Practice, E6(R1)
    International Conference on Harmonisation, November 2000, ICH Harmonisation Tripartite, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Q7
    International Conference on Harmonisation, August 2009, ICH Harmonisation Tripartite, Pharmaceutical Development, Q8
    International Conference on Harmonisation, November 2005, ICH Harmonisation Tripartite, Quality Risk Management, Q9
    International Conference on Harmonisation, June 2008, ICH Harmonisation Tripartite, Pharmaceutical Quality System, Q10
    The Global Harmonization Task Force, January 2004, Quality Management Systems – Process Validation Guidance
    U.S Food and Drug Administration, September 2004, Pharmaceutical CGMPS for the 21st Century — A Risk-based Approach Final Report
    U.S Food and Drug Administration, August 2013, Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
    U.S Food and Drug Administration, September 2004, Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
    U.S Food and Drug Administration, January 2011, Guidance for Industry Process Validation: General Principles and Practices
    U.S Food and Drug Administration, September 2006, Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations

  • Learning & Teaching Activities
    Learning & Teaching Modes
    This course will use a mixture of activities to teach the elements of regulatory affairs, validation and Good Manufacturing Practice (GMP) that form an important part of ensuring the manufacturing of safe and efficacious pharmaceutical products and medical devices. The core teaching material will be provided as prerecorded lectures so the student can access this material throughout the course. There is an extensive reading list of regulatory guidance documents with precorded reading guidance to aid the student. There will also be face-to-face tutorials which will cover the key teaching outcomes and provide an informal environment to learn how clinical tials, validation, and GMP are applied to pharmaceutical processes. It also provides an opportunity to ask questions.   

    The information below is provided as a guide to assist students in engaging appropriately with the course requirements.

    A student enrolled in a 3-unit course, such as this, should expect to spend, on average 12 hours per week on the studies required. This includes both the formal contact time required to the course (e.g., lectures and practicals), as well as non-contact time (e.g., reading and revision).
    Learning Activities Summary
    Explain the regulatory basics for process validation and outline the prospective validation

    Code of GMP, ICH guidlines, Regulatory bodies (FDA, EMA, TGA), Quality by design, process design

    Use the GMP regulation regarding the ultilities n Pharmaceutical manufacturing
    Clean room, water for injection, cleaning, sterilization, air/product flow, personell flow, design of facilities, hygienic design

    Apply the validation of sterilization, lyophilisation and solid dosages forms
    Kinetics, HACCP, analytics, precision, accurace, ruggendness

    Explain the process of pharmaceutcial packaging and quality control
    Traceability, sampling 

    Assess the environmental impact of a industrial process.
    Waste water, air flow and design of facilities

    Demonstrate the process of validation and quality assurance
    Design model facility to produce pharmaceuticals

    Examine the harmonization, GMPs and validations in global level
    Regulatory bodies (FDA, EMA, TGA)
  • Assessment

    The University's policy on Assessment for Coursework Programs is based on the following four principles:

    1. Assessment must encourage and reinforce learning.
    2. Assessment must enable robust and fair judgements about student performance.
    3. Assessment practices must be fair and equitable to students and give them the opportunity to demonstrate what they have learned.
    4. Assessment must maintain academic standards.

    Assessment Summary
    Assessment Task Weighting (%) Individual/ Group Formative/ Summative
    Due (week)*
    Hurdle criteria Learning outcomes
    Mid Semester Quiz 10 Individual Paper based 4 1,2,3,7
    End of Semester Quiz 10 Individual Paper based 7 3,4,5,6
    Assignment 1 40 Individual Report 4 3,4
    Assignment 2 40 Individual Report 7 3,4,5,6
    Total 100

    * The specific due date for each assessment task will be available on MyUni.
    This assessment breakdown complies with the University's Assessment for Coursework Programs Policy.
    Assessment Detail
    The assessment will comprise mid and end of course tests to ensure the breadth of the material is being learnt and to ensure the students are keeping up to date with the teaching material. The assignments will ensure the students will engage with the validation, the facility design, and the GMP elements of the course in more depth.
    The details of the assignment submission process will be provided in the prerecorded assignment information and in the paperwork in MyUni.
    Course Grading

    Grades for your performance in this course will be awarded in accordance with the following scheme:

    M10 (Coursework Mark Scheme)
    Grade Mark Description
    FNS   Fail No Submission
    F 1-49 Fail
    P 50-64 Pass
    C 65-74 Credit
    D 75-84 Distinction
    HD 85-100 High Distinction
    CN   Continuing
    NFE   No Formal Examination
    RP   Result Pending

    Further details of the grades/results can be obtained from Examinations.

    Grade Descriptors are available which provide a general guide to the standard of work that is expected at each grade level. More information at Assessment for Coursework Programs.

    Final results for this course will be made available through Access Adelaide.

  • Student Feedback

    The University places a high priority on approaches to learning and teaching that enhance the student experience. Feedback is sought from students in a variety of ways including on-going engagement with staff, the use of online discussion boards and the use of Student Experience of Learning and Teaching (SELT) surveys as well as GOS surveys and Program reviews.

    SELTs are an important source of information to inform individual teaching practice, decisions about teaching duties, and course and program curriculum design. They enable the University to assess how effectively its learning environments and teaching practices facilitate student engagement and learning outcomes. Under the current SELT Policy ( course SELTs are mandated and must be conducted at the conclusion of each term/semester/trimester for every course offering. Feedback on issues raised through course SELT surveys is made available to enrolled students through various resources (e.g. MyUni). In addition aggregated course SELT data is available.

  • Student Support
  • Policies & Guidelines
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