CHEM ENG 4036 - Pharmaceutical Process Validation & Quality

North Terrace Campus - Semester 2 - 2021

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 CHEM ENG 4036
    Course Pharmaceutical Process Validation & Quality
    Coordinating Unit School of Chemical Eng and Advanced Materials(Ina)
    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
    Assessment Assignments, project reports, final examination
    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 Explain the regulatory basics for process validation and outline the prospective validation
    2 Use the GMP regulation regarding the ultilities n Pharmaceutical manufacturing
    3 Apply the validation of sterilization, lyophilisation and solid dosages forms
    4 Explain the process of pharmaceutcial packaging and quality control
    5 Assess the environmental impact of a industrial process.
    6 Demonstrate the process of validation and quality assurance
    7 Examine the harmonization, GMPs and validations in global level

     
    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)
    Deep discipline knowledge
    • informed and infused by cutting edge research, scaffolded throughout their program of studies
    • acquired from personal interaction with research active educators, from year 1
    • accredited or validated against national or international standards (for relevant programs)
    1-4
    Critical thinking and problem solving
    • steeped in research methods and rigor
    • based on empirical evidence and the scientific approach to knowledge development
    • demonstrated through appropriate and relevant assessment
    1-4
    Teamwork and communication skills
    • developed from, with, and via the SGDE
    • honed through assessment and practice throughout the program of studies
    • encouraged and valued in all aspects of learning
    1-7
    Career and leadership readiness
    • technology savvy
    • professional and, where relevant, fully accredited
    • forward thinking and well informed
    • tested and validated by work based experiences
    1-7
    Intercultural and ethical competency
    • adept at operating in other cultures
    • comfortable with different nationalities and social contexts
    • able to determine and contribute to desirable social outcomes
    • demonstrated by study abroad or with an understanding of indigenous knowledges
    5-7
    Self-awareness and emotional intelligence
    • a capacity for self-reflection and a willingness to engage in self-appraisal
    • open to objective and constructive feedback from supervisors and peers
    • able to negotiate difficult social situations, defuse conflict and engage positively in purposeful debate
    5-7
  • Learning Resources
    Recommended Resources
    Reference Books

    Robert A. Nash and Alfred H. Wachter, Pharmaceutical Process Validation, Marcel Dekker Inc., New York. Basel. 2003

    Michael Levin, Pharmaceutical Process Scale-Up. Taylor & Francis, 2005

    Andrew A. Signore, Terry Jacobs, Good Design Practices for GMP Pharmaceutical Facilities, Taylor & Francis, 2005

  • Learning & Teaching Activities
    Learning & Teaching Modes

    No information currently available.

    Workload

    No information currently available.

    Learning Activities Summary

    No information currently available.

  • 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
    Further information will be available prior to the start of the Semester.
    Total 0
    * 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

    No information currently available.

    Submission

    No information currently available.

    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 (http://www.adelaide.edu.au/policies/101/) 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
  • Fraud Awareness

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